Trial Outcomes & Findings for Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury (NCT NCT00313716)
NCT ID: NCT00313716
Last Updated: 2014-09-10
Results Overview
Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
200 participants
Primary outcome timeframe
at 6 months after injury
Results posted on
2014-09-10
Participant Flow
Participant milestones
| Measure |
Epo1/TT7 Arm
High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
|
Epo2/TT7 Arm
Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
|
Placebo/TT7 Arm
Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
|
Epo1/TT10 Arm
High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
|
Epo2/TT10 Arm
Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
|
Placebo/TT10 Arm
Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
31
|
50
|
20
|
33
|
48
|
|
Overall Study
COMPLETED
|
13
|
23
|
38
|
16
|
27
|
35
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
12
|
4
|
6
|
13
|
Reasons for withdrawal
| Measure |
Epo1/TT7 Arm
High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
|
Epo2/TT7 Arm
Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
|
Placebo/TT7 Arm
Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
|
Epo1/TT10 Arm
High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
|
Epo2/TT10 Arm
Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
|
Placebo/TT10 Arm
Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
9
|
3
|
5
|
9
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
2
|
1
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Epo1/TT7 Arm
n=18 Participants
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl
|
Epo2/TT7 Arm
n=31 Participants
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
|
Placebo/TT7 Arm
n=50 Participants
Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl
|
Epo1/TT10 Arm
n=20 Participants
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl
|
Epo2/TT10 Arm
n=33 Participants
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl
|
Placebo/TT10 Arm
n=48 Participants
Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
43 Participants
n=10 Participants
|
174 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
8 participants
n=5 Participants
|
16 participants
n=7 Participants
|
26 participants
n=5 Participants
|
12 participants
n=4 Participants
|
19 participants
n=21 Participants
|
22 participants
n=10 Participants
|
103 participants
n=115 Participants
|
|
Age, Continuous
|
25.5 years
n=5 Participants
|
28 years
n=7 Participants
|
29.5 years
n=5 Participants
|
36.5 years
n=4 Participants
|
30 years
n=21 Participants
|
30.5 years
n=10 Participants
|
30 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
14 participants
n=10 Participants
|
43 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
11 participants
n=5 Participants
|
5 participants
n=4 Participants
|
8 participants
n=21 Participants
|
9 participants
n=10 Participants
|
48 participants
n=115 Participants
|
|
Prehospital hypotension
yes
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
9 participants
n=10 Participants
|
25 participants
n=115 Participants
|
|
Prehospital hypotension
no
|
17 participants
n=5 Participants
|
28 participants
n=7 Participants
|
43 participants
n=5 Participants
|
17 participants
n=4 Participants
|
31 participants
n=21 Participants
|
39 participants
n=10 Participants
|
175 participants
n=115 Participants
|
|
Prehospital hypoxia
yes
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
16 participants
n=5 Participants
|
3 participants
n=4 Participants
|
5 participants
n=21 Participants
|
13 participants
n=10 Participants
|
39 participants
n=115 Participants
|
|
Prehospital hypoxia
no
|
18 participants
n=5 Participants
|
29 participants
n=7 Participants
|
34 participants
n=5 Participants
|
17 participants
n=4 Participants
|
28 participants
n=21 Participants
|
35 participants
n=10 Participants
|
161 participants
n=115 Participants
|
|
Mechanism of injury
Assault
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
3 participants
n=21 Participants
|
10 participants
n=10 Participants
|
22 participants
n=115 Participants
|
|
Mechanism of injury
Fall or jump
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
2 participants
n=10 Participants
|
27 participants
n=115 Participants
|
|
Mechanism of injury
Automobile crash
|
10 participants
n=5 Participants
|
19 participants
n=7 Participants
|
29 participants
n=5 Participants
|
9 participants
n=4 Participants
|
22 participants
n=21 Participants
|
27 participants
n=10 Participants
|
116 participants
n=115 Participants
|
|
Mechanism of injury
Motorcycle crash
|
0 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
5 participants
n=4 Participants
|
4 participants
n=21 Participants
|
8 participants
n=10 Participants
|
31 participants
n=115 Participants
|
|
Mechanism of injury
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
Injury Severity Score
|
29 units on a scale
n=5 Participants
|
30 units on a scale
n=7 Participants
|
29 units on a scale
n=5 Participants
|
27 units on a scale
n=4 Participants
|
29 units on a scale
n=21 Participants
|
29 units on a scale
n=10 Participants
|
29 units on a scale
n=115 Participants
|
|
IMPACT probability of poor outcome
|
.29 probability of poor outcome
STANDARD_DEVIATION .2 • n=5 Participants
|
.35 probability of poor outcome
STANDARD_DEVIATION .2 • n=7 Participants
|
.45 probability of poor outcome
STANDARD_DEVIATION .3 • n=5 Participants
|
.49 probability of poor outcome
STANDARD_DEVIATION .2 • n=4 Participants
|
.46 probability of poor outcome
STANDARD_DEVIATION .3 • n=21 Participants
|
.38 probability of poor outcome
STANDARD_DEVIATION .3 • n=10 Participants
|
.41 probability of poor outcome
STANDARD_DEVIATION .25 • n=115 Participants
|
|
Motor component of Glasgow Coma Score
mGCS 1-3
|
4 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
8 participants
n=4 Participants
|
14 participants
n=21 Participants
|
13 participants
n=10 Participants
|
71 participants
n=115 Participants
|
|
Motor component of Glasgow Coma Score
mGCS 4-5
|
14 participants
n=5 Participants
|
19 participants
n=7 Participants
|
30 participants
n=5 Participants
|
12 participants
n=4 Participants
|
19 participants
n=21 Participants
|
35 participants
n=10 Participants
|
129 participants
n=115 Participants
|
|
Sum Glasgow Coma Score
GCS 3-5
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
8 participants
n=4 Participants
|
13 participants
n=21 Participants
|
11 participants
n=10 Participants
|
66 participants
n=115 Participants
|
|
Sum Glasgow Coma Score
GCS 6-8
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
19 participants
n=5 Participants
|
8 participants
n=4 Participants
|
16 participants
n=21 Participants
|
23 participants
n=10 Participants
|
89 participants
n=115 Participants
|
|
Sum Glasgow Coma Score
GCS > 8
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
11 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
14 participants
n=10 Participants
|
45 participants
n=115 Participants
|
|
Pupil reactivity
Both reactive
|
12 participants
n=5 Participants
|
24 participants
n=7 Participants
|
27 participants
n=5 Participants
|
13 participants
n=4 Participants
|
17 participants
n=21 Participants
|
28 participants
n=10 Participants
|
121 participants
n=115 Participants
|
|
Pupil reactivity
One reactive
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
3 participants
n=4 Participants
|
1 participants
n=21 Participants
|
5 participants
n=10 Participants
|
23 participants
n=115 Participants
|
|
Pupil reactivity
Neither reactive
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
15 participants
n=5 Participants
|
4 participants
n=4 Participants
|
15 participants
n=21 Participants
|
15 participants
n=10 Participants
|
56 participants
n=115 Participants
|
|
Marshall CT scan category
Diffuse injury 1 or 2
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
24 participants
n=5 Participants
|
5 participants
n=4 Participants
|
15 participants
n=21 Participants
|
20 participants
n=10 Participants
|
89 participants
n=115 Participants
|
|
Marshall CT scan category
Diffuse injury 3 or 4
|
5 participants
n=5 Participants
|
8 participants
n=7 Participants
|
10 participants
n=5 Participants
|
9 participants
n=4 Participants
|
2 participants
n=21 Participants
|
12 participants
n=10 Participants
|
46 participants
n=115 Participants
|
|
Marshall CT scan category
Mass lesion
|
3 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
6 participants
n=4 Participants
|
16 participants
n=21 Participants
|
16 participants
n=10 Participants
|
65 participants
n=115 Participants
|
|
Presence of subarachnoid hemorrhage
yes
|
12 participants
n=5 Participants
|
22 participants
n=7 Participants
|
37 participants
n=5 Participants
|
3 participants
n=4 Participants
|
22 participants
n=21 Participants
|
11 participants
n=10 Participants
|
107 participants
n=115 Participants
|
|
Presence of subarachnoid hemorrhage
no
|
6 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
17 participants
n=4 Participants
|
11 participants
n=21 Participants
|
37 participants
n=10 Participants
|
93 participants
n=115 Participants
|
|
Presence of epidural hematoma
yes
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
8 participants
n=21 Participants
|
11 participants
n=10 Participants
|
32 participants
n=115 Participants
|
|
Presence of epidural hematoma
no
|
15 participants
n=5 Participants
|
27 participants
n=7 Participants
|
47 participants
n=5 Participants
|
17 participants
n=4 Participants
|
25 participants
n=21 Participants
|
37 participants
n=10 Participants
|
168 participants
n=115 Participants
|
|
Hemoglobin concentration
|
14.7 g/dl
n=5 Participants
|
14.7 g/dl
n=7 Participants
|
14.0 g/dl
n=5 Participants
|
14.8 g/dl
n=4 Participants
|
13.9 g/dl
n=21 Participants
|
14.7 g/dl
n=10 Participants
|
14.45 g/dl
n=115 Participants
|
|
Glucose concentration
|
8.3 mmol/L
n=5 Participants
|
9.1 mmol/L
n=7 Participants
|
8.9 mmol/L
n=5 Participants
|
8.8 mmol/L
n=4 Participants
|
8.6 mmol/L
n=21 Participants
|
7.7 mmol/L
n=10 Participants
|
8.42 mmol/L
n=115 Participants
|
|
Surgery on admission
Evacuation epidural hematoma
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
5 participants
n=10 Participants
|
9 participants
n=115 Participants
|
|
Surgery on admission
Evacuation subdural hematoma
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
5 participants
n=4 Participants
|
14 participants
n=21 Participants
|
7 participants
n=10 Participants
|
46 participants
n=115 Participants
|
|
Surgery on admission
Evacuation intracerebral hematoma or contusion
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
4 participants
n=115 Participants
|
|
Surgery on admission
Non-central nervous system injury
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Surgery on admission
No surgery on admission
|
15 participants
n=5 Participants
|
24 participants
n=7 Participants
|
34 participants
n=5 Participants
|
14 participants
n=4 Participants
|
18 participants
n=21 Participants
|
34 participants
n=10 Participants
|
139 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: at 6 months after injuryPopulation: Intention to treat. Multiple imputation for missing 6-month GOS data was performed assuming data were missing at random using chained equations (R, R Foundation for Statistical Computing).The imputation was based on a logistic regression model with baseline covariates. Results were aggregated over 20 imputed sets using variance formula by Rubin.
Dichotomized to favorable outcome (good recovery or moderate disability) or to unfavorable outcome (severe disability or vegetative or dead)
Outcome measures
| Measure |
Epo1 Group
n=35 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Epo2 Group
n=57 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
|
Placebo Group
n=89 Participants
Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
|
TT7 Group
n=87 Participants
Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
|
TT10 Group
n=94 Participants
Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
|
|---|---|---|---|---|---|
|
Glasgow Outcome Scale
Favorable outcome
|
17 participants
|
17 participants
|
34 participants
|
37 participants
|
31 participants
|
|
Glasgow Outcome Scale
Unfavorable outcome
|
18 participants
|
40 participants
|
55 participants
|
50 participants
|
63 participants
|
SECONDARY outcome
Timeframe: at 6 monthsPopulation: Intention to treat analysis
Disability rating scale was a secondary outcome measure for the transfusion threshold analysis. Disability rating scale ranges from 0 to 30, with 30 indicating death and 0 indicating return to normal status.
Outcome measures
| Measure |
Epo1 Group
n=87 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Epo2 Group
n=94 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
|
Placebo Group
Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
|
TT7 Group
Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
|
TT10 Group
Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
|
|---|---|---|---|---|---|
|
Disability Rating Scale
|
5 units on a scale
Interval 2.25 to 9.75
|
8 units on a scale
Interval 4.0 to 17.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 6 months after injuryPopulation: Intention to treat analysis
mortality rate was a secondary outcome measure for the Epo randomization, and a primary safety outcome measure for the transfusion threshold randomization
Outcome measures
| Measure |
Epo1 Group
n=38 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Epo2 Group
n=64 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
|
Placebo Group
n=98 Participants
Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
|
TT7 Group
n=99 Participants
Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
|
TT10 Group
n=101 Participants
Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
|
|---|---|---|---|---|---|
|
Mortality Rate
Died
|
6 participants
|
7 participants
|
18 participants
|
14 participants
|
17 participants
|
|
Mortality Rate
Survived
|
32 participants
|
57 participants
|
80 participants
|
85 participants
|
84 participants
|
SECONDARY outcome
Timeframe: within 30 days after injuryPopulation: Intention to treat analysis
development of ARDS was a primary safety outcome for the transfusion threshold randomization
Outcome measures
| Measure |
Epo1 Group
n=99 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Epo2 Group
n=101 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
|
Placebo Group
Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
|
TT7 Group
Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
|
TT10 Group
Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
|
|---|---|---|---|---|---|
|
Incidence of Adult Respiratory Distress Syndrome (ARDS)
Developed ARDS
|
16 participants
|
25 participants
|
—
|
—
|
—
|
|
Incidence of Adult Respiratory Distress Syndrome (ARDS)
Did not develop ARDS
|
83 participants
|
76 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: within 30 days after injuryPopulation: Intention to treat analysis
occurrence of infection was a primary safety outcome for the transfusion threshold randomization
Outcome measures
| Measure |
Epo1 Group
n=99 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Epo2 Group
n=101 Participants
Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
|
Placebo Group
Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
|
TT7 Group
Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
|
TT10 Group
Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
|
|---|---|---|---|---|---|
|
Incidence of Infection
Developed one or more infections
|
27 participants
|
36 participants
|
—
|
—
|
—
|
|
Incidence of Infection
Did not develop infection
|
72 participants
|
65 participants
|
—
|
—
|
—
|
Adverse Events
Epo1 Group
Serious events: 29 serious events
Other events: 34 other events
Deaths: 0 deaths
Epo2 Group
Serious events: 50 serious events
Other events: 57 other events
Deaths: 0 deaths
Placebo Group
Serious events: 78 serious events
Other events: 87 other events
Deaths: 0 deaths
TT7 Group
Serious events: 85 serious events
Other events: 85 other events
Deaths: 0 deaths
TT10 Group
Serious events: 93 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epo1 Group
n=38 participants at risk
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Epo2 Group
n=64 participants at risk
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Placebo Group
n=98 participants at risk
Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
|
TT7 Group
n=99 participants at risk
Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
|
TT10 Group
n=101 participants at risk
Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Electrolyte disturbance
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.2%
4/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
7.1%
7/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.1%
5/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.9%
6/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
Shock
|
26.3%
10/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
23.4%
15/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
19.4%
19/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
25.3%
25/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
18.8%
19/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Severe atelectasis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Gastrointestinal disorders
incarcerated inguinal hernia
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Brain death
|
7.9%
3/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.1%
5/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.1%
6/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Brain tissue hypoxia
|
7.9%
3/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.2%
4/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
8.2%
8/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
10.1%
10/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.0%
5/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
delayed or recurrent intracranial hemorrhage
|
26.3%
10/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
20.3%
13/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
18.4%
18/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
15.2%
15/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
25.7%
26/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
hydrocephalus
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
intracranial hypertension
|
18.4%
7/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
21.9%
14/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
28.6%
28/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
22.2%
22/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
26.7%
27/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
meningitis or ventriculitis
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
wound dehiscence
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
stroke
|
7.9%
3/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Vascular disorders
Lower extremity deep venous thrombophlebitis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
acute myocardial infarction
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
cardiac arrest with CPR
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Vascular disorders
Gangrene of extremities
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
Hypotension due to barbiturate coma
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.2%
4/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.1%
6/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
8.9%
9/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Vascular disorders
Upper extremity deep venous thrombophlebitis
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
Pulmonary embolus
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.2%
4/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
3/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.9%
6/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Gastrointestinal disorders
peritonitis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Blood and lymphatic system disorders
Severe anemia
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Blood and lymphatic system disorders
Other severe hematologic disorder
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Multiple organ dysfunction syndrome
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Wound infection, non-central nervous system
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Pneumonia
|
28.9%
11/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
12.5%
8/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
14.3%
14/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
13.1%
13/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
19.8%
20/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Sepsis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Septic shock
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Endocrine disorders
Diabetes insipidus
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
8.2%
8/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
7.1%
7/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Carotid cavernous fistula
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Infected eye injury
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Hemothorax
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Osteomyelitis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Rhabdomyalysis
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Tongue laceration
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
internal jugular vein injury
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Renal and urinary disorders
Acute renal failure
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
3/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Renal and urinary disorders
Severe metabolic acidosis
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Renal and urinary disorders
Severe mixed acid-base disorder
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
7.9%
3/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.1%
6/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
8.9%
9/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Airway obstruction post-extubation
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
Other adverse events
| Measure |
Epo1 Group
n=38 participants at risk
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Epo2 Group
n=64 participants at risk
Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
|
Placebo Group
n=98 participants at risk
Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
|
TT7 Group
n=99 participants at risk
Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
|
TT10 Group
n=101 participants at risk
Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
63.2%
24/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
51.6%
33/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
61.2%
60/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
66.7%
66/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
50.5%
51/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Blood and lymphatic system disorders
Other hematologic disorder
|
34.2%
13/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
31.2%
20/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
43.9%
43/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
37.4%
37/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
38.6%
39/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
7.8%
5/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
7.1%
7/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
7.1%
7/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.9%
6/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Bacteremia
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
3/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Wound infection, non-central nervous system
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Metabolism and nutrition disorders
Diffuse edema
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Endocrine disorders
Hyperglycemia
|
7.9%
3/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.1%
4/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Endocrine disorders
Hypoglycemia
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Metabolism and nutrition disorders
Hypothermia
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Bleeding complicating a procedure
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Skin and subcutaneous tissue disorders
Decubitis ulcer
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Eye disorders
Exposure keratoconjunctivitis
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Rhabdomyalysis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Renal and urinary disorders
acute renal dysfunction
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.1%
5/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Renal and urinary disorders
Metabolic acidosis
|
7.9%
3/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.1%
4/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Renal and urinary disorders
Mixed acid-base abnormality
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Airway obstruction post-extubation
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
36.8%
14/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
21.9%
14/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
19.4%
19/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
21.2%
21/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
25.7%
26/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.1%
6/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.1%
6/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.1%
6/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Febrile transfusion reaction
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Renal and urinary disorders
Electrolyte imbalance
|
31.6%
12/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
31.2%
20/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
36.7%
36/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
28.3%
28/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
39.6%
40/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Cerebrospinal fluid leak
|
5.3%
2/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Brain tissue hypoxia
|
23.7%
9/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
18.8%
12/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
21.4%
21/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
21.2%
21/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
20.8%
21/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Delayed or recurrent intracranial hematoma
|
18.4%
7/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
7.8%
5/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
12.2%
12/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
11.1%
11/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
12.9%
13/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Hydrocephalus
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Intracranial hypertension
|
23.7%
9/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
14.1%
9/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
15.3%
15/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
17.2%
17/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
15.8%
16/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Pneumocephalus
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Infections and infestations
Wound infection
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Seizure
|
7.9%
3/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.7%
3/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.1%
5/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.0%
4/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.9%
7/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Nervous system disorders
Subgaleal cerebrospinal fluid collection
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Vascular disorders
Lower extremity deep venous thrombophlebitis
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.1%
2/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
4.1%
4/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
5.0%
5/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
Atrial arrhythmia
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
Hypertension
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
Hypotension from barbiturate coma
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Vascular disorders
Upper extremity deep vein thrombophlebitis
|
18.4%
7/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
10.9%
7/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
6.1%
6/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
10.1%
10/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
9.9%
10/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Cardiac disorders
Hypotension
|
2.6%
1/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
2.0%
2/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
3.0%
3/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Gastrointestinal disorders
Upper GI bleeding
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.6%
1/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.99%
1/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Hepatobiliary disorders
Elevated transaminases
|
28.9%
11/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
21.9%
14/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
26.5%
26/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
25.3%
25/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
25.7%
26/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/38 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/64 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/98 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
1.0%
1/99 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
0.00%
0/101 • Serious adverse events were reported for 30 days after injury
Each patient is represented twice in the table (once in the Epo1/Epo2/Placebo groups and once in the TT7/TT10 groups)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place