Trial Outcomes & Findings for Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood (NCT NCT01251042)
NCT ID: NCT01251042
Last Updated: 2021-11-11
Results Overview
Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)
Results posted on
2021-11-11
Participant Flow
51 subjects were enrolled but 2 subjects were never randomized and have thus not been included in the analysis.
Participant milestones
| Measure |
Sangvia and Retransfusion
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Return and Wastage of Your Own Blood, Collected During Spinal Surgery, for Verification of Safety When Returning Blood
Baseline characteristics by cohort
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 14 • n=5 Participants
|
59 years
STANDARD_DEVIATION 13 • n=7 Participants
|
56 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At screening and 24 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Difference in plasma free hemoglobin (p-Hb) concentration between screening and 24 hours after surgery
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Difference in Plasma Free Hemoglobin (p-Hb) Concentration
|
0.1 g/l
Standard Deviation 0.2
|
0.0 g/l
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic plasma free hemoglobin (p-Hb) concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Plasma Free Hemoglobin (p-Hb) Concentration
Screening
|
0.2 g/l
Standard Deviation 0.2 • Interval -0.0288 to 0.1208
|
0.1 g/l
Standard Deviation 0.1
|
|
Plasma Free Hemoglobin (p-Hb) Concentration
At Randomization (0 hrs)
|
0.2 g/l
Standard Deviation 0.2
|
0.2 g/l
Standard Deviation 0.2
|
|
Plasma Free Hemoglobin (p-Hb) Concentration
End of transfusion
|
1.2 g/l
Standard Deviation 0.7
|
NA g/l
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Plasma Free Hemoglobin (p-Hb) Concentration
3 hours
|
0.9 g/l
Standard Deviation 0.7
|
0.1 g/l
Standard Deviation 0.1
|
|
Plasma Free Hemoglobin (p-Hb) Concentration
6 hours
|
0.5 g/l
Standard Deviation 0.1
|
0.0 g/l
Standard Deviation 0.1
|
|
Plasma Free Hemoglobin (p-Hb) Concentration
24 hours
|
0.1 g/l
Standard Deviation 0.1
|
0.1 g/l
Standard Deviation 0.1
|
|
Plasma Free Hemoglobin (p-Hb) Concentration
48 hours
|
0.1 g/l
Standard Deviation 0.1
|
0.1 g/l
Standard Deviation 0.3
|
|
Plasma Free Hemoglobin (p-Hb) Concentration
96 hours
|
0.1 g/l
Standard Deviation 0.2
|
01. g/l
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic hemoglobin concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Hemoglobin Concentration
Screening
|
14.2 g/dl
Standard Deviation 1.1
|
13.8 g/dl
Standard Deviation 1.3
|
|
Hemoglobin Concentration
At Randomization (0 hrs)
|
11.8 g/dl
Standard Deviation 1.1
|
11.1 g/dl
Standard Deviation 1.5
|
|
Hemoglobin Concentration
End of transfusion
|
12.5 g/dl
Standard Deviation 1.1
|
NA g/dl
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Hemoglobin Concentration
3 hours
|
12.5 g/dl
Standard Deviation 1.1
|
11.6 g/dl
Standard Deviation 1.3
|
|
Hemoglobin Concentration
6 hours
|
12.4 g/dl
Standard Deviation 1.2
|
11.5 g/dl
Standard Deviation 1.2
|
|
Hemoglobin Concentration
24 hours
|
11.6 g/dl
Standard Deviation 1.2
|
10.8 g/dl
Standard Deviation 1.2
|
|
Hemoglobin Concentration
48 hours
|
11.4 g/dl
Standard Deviation 1.0
|
10.8 g/dl
Standard Deviation 1.7
|
|
Hemoglobin Concentration
96 hours
|
11.2 g/dl
Standard Deviation 1.3
|
10.9 g/dl
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic potassium concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Potassium Concentration
96 hours
|
4.0 mmol/l
Standard Deviation 0.4
|
4.0 mmol/l
Standard Deviation 0.5
|
|
Potassium Concentration
Screening
|
4.2 mmol/l
Standard Deviation 0.3
|
4.4 mmol/l
Standard Deviation 0.4
|
|
Potassium Concentration
At Randomization (0 hrs)
|
4.2 mmol/l
Standard Deviation 0.4
|
4.1 mmol/l
Standard Deviation 0.7
|
|
Potassium Concentration
End of transfusion
|
4.1 mmol/l
Standard Deviation 0.4
|
NA mmol/l
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Potassium Concentration
3 hours
|
4.0 mmol/l
Standard Deviation 0.4
|
4.3 mmol/l
Standard Deviation 0.4
|
|
Potassium Concentration
6 hours
|
4.2 mmol/l
Standard Deviation 0.5
|
4.3 mmol/l
Standard Deviation 0.4
|
|
Potassium Concentration
24 hours
|
3.9 mmol/l
Standard Deviation 0.3
|
4.0 mmol/l
Standard Deviation 0.4
|
|
Potassium Concentration
48 hours
|
4.0 mmol/l
Standard Deviation 0.6
|
4.0 mmol/l
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic creatinine concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Creatinine Concentration
Screening
|
64 μmol/l
Standard Deviation 13
|
70 μmol/l
Standard Deviation 15
|
|
Creatinine Concentration
At Randomization (0 hrs)
|
65 μmol/l
Standard Deviation 12
|
69 μmol/l
Standard Deviation 16
|
|
Creatinine Concentration
End of transfusion
|
68 μmol/l
Standard Deviation 13
|
NA μmol/l
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Creatinine Concentration
3 hours
|
66 μmol/l
Standard Deviation 12
|
72 μmol/l
Standard Deviation 16
|
|
Creatinine Concentration
6 hours
|
62 μmol/l
Standard Deviation 12
|
64 μmol/l
Standard Deviation 12
|
|
Creatinine Concentration
24 hours
|
61 μmol/l
Standard Deviation 12
|
66 μmol/l
Standard Deviation 17
|
|
Creatinine Concentration
48 hours
|
62 μmol/l
Standard Deviation 12
|
67 μmol/l
Standard Deviation 16
|
|
Creatinine Concentration
96 hours
|
59 μmol/l
Standard Deviation 12
|
64 μmol/l
Standard Deviation 14
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic IL-1-α concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Interleukin-1-alpha (IL-1-α) Concentration
Screening
|
18.36 pg/ml
Standard Deviation 24.14
|
23.44 pg/ml
Standard Deviation 36.30
|
|
Interleukin-1-alpha (IL-1-α) Concentration
At Randomization (0 hrs)
|
13.66 pg/ml
Standard Deviation 18.37
|
22.39 pg/ml
Standard Deviation 37.35
|
|
Interleukin-1-alpha (IL-1-α) Concentration
End of transfusion
|
14.97 pg/ml
Standard Deviation 16.21
|
NA pg/ml
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Interleukin-1-alpha (IL-1-α) Concentration
3 hours
|
14.04 pg/ml
Standard Deviation 17.17
|
26.69 pg/ml
Standard Deviation 51.07
|
|
Interleukin-1-alpha (IL-1-α) Concentration
24 hours
|
12.45 pg/ml
Standard Deviation 14.26
|
22.16 pg/ml
Standard Deviation 34.34
|
|
Interleukin-1-alpha (IL-1-α) Concentration
48 hours
|
12.63 pg/ml
Standard Deviation 15.06
|
15.74 pg/ml
Standard Deviation 14.47
|
|
Interleukin-1-alpha (IL-1-α) Concentration
96 hours
|
13.44 pg/ml
Standard Deviation 16.15
|
17.41 pg/ml
Standard Deviation 14.10
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic IL-6 concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Interleukin-6 (IL-6) Concentration
3 hours
|
58.29 pg/ml
Standard Deviation 87.34
|
64.20 pg/ml
Standard Deviation 93.69
|
|
Interleukin-6 (IL-6) Concentration
24 hours
|
116.65 pg/ml
Standard Deviation 171.29
|
118.89 pg/ml
Standard Deviation 192.73
|
|
Interleukin-6 (IL-6) Concentration
48 hours
|
118.05 pg/ml
Standard Deviation 163.19
|
163.73 pg/ml
Standard Deviation 188.09
|
|
Interleukin-6 (IL-6) Concentration
96 hours
|
29.14 pg/ml
Standard Deviation 24.00
|
32.51 pg/ml
Standard Deviation 19.15
|
|
Interleukin-6 (IL-6) Concentration
Screening
|
8.35 pg/ml
Standard Deviation 9.38
|
8.94 pg/ml
Standard Deviation 10.45
|
|
Interleukin-6 (IL-6) Concentration
At Randomization (0 hrs)
|
7.27 pg/ml
Standard Deviation 6.12
|
9.71 pg/ml
Standard Deviation 9.71
|
|
Interleukin-6 (IL-6) Concentration
End of transfusion
|
37.30 pg/ml
Standard Deviation 46.00
|
NA pg/ml
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic IL-8 concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Interleukin-8 (IL-8) Concentration
Screening
|
1.35 pg/ml
Standard Deviation 1.07
|
1.35 pg/ml
Standard Deviation 0.76
|
|
Interleukin-8 (IL-8) Concentration
At Randomization (0 hrs)
|
2.34 pg/ml
Standard Deviation 2.67
|
2.01 pg/ml
Standard Deviation 2.54
|
|
Interleukin-8 (IL-8) Concentration
End of transfusion
|
4.32 pg/ml
Standard Deviation 6.41
|
NA pg/ml
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Interleukin-8 (IL-8) Concentration
3 hours
|
5.17 pg/ml
Standard Deviation 9.14
|
2.91 pg/ml
Standard Deviation 2.79
|
|
Interleukin-8 (IL-8) Concentration
24 hours
|
2.05 pg/ml
Standard Deviation 1.53
|
3.13 pg/ml
Standard Deviation 2.33
|
|
Interleukin-8 (IL-8) Concentration
48 hours
|
2.57 pg/ml
Standard Deviation 2.27
|
3.77 pg/ml
Standard Deviation 2.88
|
|
Interleukin-8 (IL-8) Concentration
96 hours
|
2.48 pg/ml
Standard Deviation 1.96
|
2.70 pg/ml
Standard Deviation 1.61
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic IL-10 concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Interleukin-10 (IL-10) Concentration
Screening
|
2.25 pg/ml
Standard Deviation 2.72
|
2.07 pg/ml
Standard Deviation 1.19
|
|
Interleukin-10 (IL-10) Concentration
At Randomization (0 hrs)
|
4.59 pg/ml
Standard Deviation 3.44
|
7.99 pg/ml
Standard Deviation 9.88
|
|
Interleukin-10 (IL-10) Concentration
End of transfusion
|
70.65 pg/ml
Standard Deviation 100.88
|
NA pg/ml
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Interleukin-10 (IL-10) Concentration
3 hours
|
50.60 pg/ml
Standard Deviation 81.04
|
18.36 pg/ml
Standard Deviation 18.11
|
|
Interleukin-10 (IL-10) Concentration
24 hours
|
5.29 pg/ml
Standard Deviation 4.26
|
4.27 pg/ml
Standard Deviation 2.49
|
|
Interleukin-10 (IL-10) Concentration
48 hours
|
3.54 pg/ml
Standard Deviation 1.48
|
4.96 pg/ml
Standard Deviation 3.23
|
|
Interleukin-10 (IL-10) Concentration
96 hours
|
2.15 pg/ml
Standard Deviation 1.34
|
2.67 pg/ml
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic TNF-α concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
Screening
|
25.40 pg/ml
Standard Deviation 52.70
|
15.42 pg/ml
Standard Deviation 34.15
|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
At Randomization (0 hrs)
|
16.14 pg/ml
Standard Deviation 30.51
|
13.87 pg/ml
Standard Deviation 28.37
|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
End of transfusion
|
17.43 pg/ml
Standard Deviation 28.41
|
NA pg/ml
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
3 hours
|
16.23 pg/ml
Standard Deviation 28.25
|
14.02 pg/ml
Standard Deviation 28.16
|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
24 hours
|
11.55 pg/ml
Standard Deviation 23.60
|
7.86 pg/ml
Standard Deviation 17.32
|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
48 hours
|
9.84 pg/ml
Standard Deviation 24.05
|
7.69 pg/ml
Standard Deviation 15.98
|
|
Tumor Necrosis Factor Alpha (TNF-α) Concentration
96 hours
|
10.37 pg/ml
Standard Deviation 20.56
|
5.49 pg/ml
Standard Deviation 7.71
|
SECONDARY outcome
Timeframe: At screening and up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Systemic IFN-γ concentration from screening until 96 hours after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Interferon Gamma (IFN-γ) Concentration
Screening
|
7.45 pg/ml
Standard Deviation 14.17
|
8.61 pg/ml
Standard Deviation 18.90
|
|
Interferon Gamma (IFN-γ) Concentration
At Randomization (0 hrs)
|
3.89 pg/ml
Standard Deviation 5.35
|
7.37 pg/ml
Standard Deviation 15.85
|
|
Interferon Gamma (IFN-γ) Concentration
End of transfusion
|
4.50 pg/ml
Standard Deviation 4.24
|
NA pg/ml
Standard Deviation NA
Time point End of transfusion only applicable to subjects in the investigational group (Sangvia and retransfusion).
|
|
Interferon Gamma (IFN-γ) Concentration
3 hours
|
4.54 pg/ml
Standard Deviation 5.15
|
8.31 pg/ml
Standard Deviation 19.15
|
|
Interferon Gamma (IFN-γ) Concentration
24 hours
|
3.94 pg/ml
Standard Deviation 3.12
|
7.98 pg/ml
Standard Deviation 16.78
|
|
Interferon Gamma (IFN-γ) Concentration
48 hours
|
4.00 pg/ml
Standard Deviation 3.49
|
5.94 pg/ml
Standard Deviation 7.29
|
|
Interferon Gamma (IFN-γ) Concentration
96 hours
|
4.25 pg/ml
Standard Deviation 3.60
|
7.14 pg/ml
Standard Deviation 7.18
|
SECONDARY outcome
Timeframe: After surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Estimated blood loss during and after surgery.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Mean Blood Loss Volume
Intra-operative
|
623 ml
Full Range 444 • Interval 150.0 to 2400.0
|
742 ml
Interval 200.0 to 2400.0
|
|
Mean Blood Loss Volume
Post-operative
|
392 ml
Interval 0.0 to 1150.0
|
420 ml
Interval 120.0 to 1525.0
|
|
Mean Blood Loss Volume
Total
|
1015 ml
Interval 150.0 to 3150.0
|
1162 ml
Interval 350.0 to 2800.0
|
SECONDARY outcome
Timeframe: Up until 96 hours after surgery (surgery takes place 1-7 days after screening)Population: All subjects randomized.
Outcome measures
| Measure |
Sangvia and Retransfusion
n=26 Participants
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 Participants
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Frequency of Allogenic Blood Transfusion
|
8 percentage of participants
|
22 percentage of participants
|
Adverse Events
Sangvia and Retransfusion
Serious events: 3 serious events
Other events: 23 other events
Deaths: 0 deaths
Sangvia and no Retransfusion
Serious events: 4 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sangvia and Retransfusion
n=26 participants at risk
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 participants at risk
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Infections and infestations
Wound infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/23
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial spasm
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Nervous system disorders
Nerve contusion
|
0.00%
0/26
|
4.3%
1/23 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
3.8%
1/26 • Number of events 1
|
4.3%
1/23 • Number of events 1
|
|
Infections and infestations
Wound oozing
|
3.8%
1/26 • Number of events 1
|
0.00%
0/23
|
|
Infections and infestations
Campylobacter infection
|
3.8%
1/26 • Number of events 1
|
0.00%
0/23
|
Other adverse events
| Measure |
Sangvia and Retransfusion
n=26 participants at risk
Blood collected and retransfused with Sangvia.
|
Sangvia and no Retransfusion
n=23 participants at risk
Blood collected with Sangvia but discarded, i.e. not retransfused.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
42.3%
11/26 • Number of events 11
|
26.1%
6/23 • Number of events 6
|
|
Cardiac disorders
Dizziness
|
15.4%
4/26 • Number of events 4
|
21.7%
5/23 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
11.5%
3/26 • Number of events 3
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
5/26 • Number of events 5
|
8.7%
2/23 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 1
|
13.0%
3/23 • Number of events 3
|
|
Renal and urinary disorders
Hematuria
|
15.4%
4/26 • Number of events 4
|
0.00%
0/23
|
|
Investigations
Decreased hemoglobin
|
7.7%
2/26 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
|
General disorders
Fever
|
11.5%
3/26 • Number of events 3
|
0.00%
0/23
|
|
Cardiac disorders
Syncope
|
7.7%
2/26 • Number of events 2
|
4.3%
1/23 • Number of events 1
|
Additional Information
Emma Tällberg, Clinical Research Manager
Wellspect HealthCare
Phone: +46313764000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60