Trial Outcomes & Findings for Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients (NCT NCT00566709)
NCT ID: NCT00566709
Last Updated: 2016-04-19
Results Overview
Number of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
102 participants
Primary outcome timeframe
duration of the protocol, an average of 15 days
Results posted on
2016-04-19
Participant Flow
Participant milestones
| Measure |
RBCT Based on rSO2 Value
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
46
|
51
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
RBCT Based on rSO2 Value
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Overall Study
Protocol Violation
|
5
|
0
|
Baseline Characteristics
Near Infrared Spectroscopy (NIRS) as Transfusion Indicator in Neurocritical Patients
Baseline characteristics by cohort
| Measure |
RBCT Based on rSO2 Value
n=51 Participants
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
n=51 Participants
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.2 years
STANDARD_DEVIATION 18.3 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 16.3 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Hemoglobin (g/L)
|
110.9 g/L
STANDARD_DEVIATION 21.2 • n=5 Participants
|
114 g/L
STANDARD_DEVIATION 21.6 • n=7 Participants
|
112.4 g/L
STANDARD_DEVIATION 21.3 • n=5 Participants
|
|
Arterial Hypertension (n)
Yes
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Arterial Hypertension (n)
No
|
37 participants
n=5 Participants
|
36 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Diabetes mellitus (n)
Yes
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Diabetes mellitus (n)
No
|
49 participants
n=5 Participants
|
46 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
APACHE II score
|
14.6 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 4.2 • n=7 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
GCS
|
9 units on a scale
n=5 Participants
|
9 units on a scale
n=7 Participants
|
9 units on a scale
n=5 Participants
|
|
ISS score (N=30, 27)
|
28.0 units on a scale
STANDARD_DEVIATION 9.8 • n=5 Participants
|
29.0 units on a scale
STANDARD_DEVIATION 9.6 • n=7 Participants
|
28.5 units on a scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Hunt and Hess scale (N=10, 13)
|
4.1 units on a scale
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
4.1 units on a scale
STANDARD_DEVIATION 1 • n=5 Participants
|
|
Fisher scale (N=10, 13)
|
3.9 units on a scale
STANDARD_DEVIATION 0.3 • n=5 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.4 • n=7 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Modified Grab score (N=11, 11)
|
6.7 units on a scale
STANDARD_DEVIATION 3.9 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 3 • n=7 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
PbrO2 (mm Hg) (N=17, 22)
|
21.9 mm Hg
STANDARD_DEVIATION 5.7 • n=5 Participants
|
22.8 mm Hg
STANDARD_DEVIATION 5.6 • n=7 Participants
|
22.4 mm Hg
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
CPP (mm Hg) (N=17, 22)
|
73.9 mm Hg
STANDARD_DEVIATION 18.5 • n=5 Participants
|
72.9 mm Hg
STANDARD_DEVIATION 15.6 • n=7 Participants
|
73.4 mm Hg
STANDARD_DEVIATION 16.7 • n=5 Participants
|
|
Diagnosis
Traumatic Brain Injury
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Diagnosis
Subarachnoid hemorrhage
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Diagnosis
Intra cerebral hemorrhage
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: duration of the protocol, an average of 15 daysNumber of units of packed packed red blood cell transfused, over the period that the patient was included into the protocol
Outcome measures
| Measure |
RBCT Based on rSO2 Value
n=46 Participants
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
n=51 Participants
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Number of Units of Packed Red Blood Cell Transfused
|
0.9 units
Standard Deviation 1.1
|
1.5 units
Standard Deviation 1.4
|
PRIMARY outcome
Timeframe: duration of the protocol, an average of 15 daysOutcome measures
| Measure |
RBCT Based on rSO2 Value
n=46 Participants
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
n=51 Participants
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Percentage of Transfused Patients in Each Group
|
54.3 percentage of transfused participant
|
70.5 percentage of transfused participant
|
SECONDARY outcome
Timeframe: length of the hospital stay, an average of 20 daysOutcome measures
| Measure |
RBCT Based on rSO2 Value
n=46 Participants
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
n=51 Participants
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Hospital Mortality
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: The length of ICU stay, an avarege of 17 daysOutcome measures
| Measure |
RBCT Based on rSO2 Value
n=46 Participants
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
n=51 Participants
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Length of Intensive Care Unit (ICU) Stay
|
21.00 days
Standard Deviation 10.23
|
20.41 days
Standard Deviation 11.06
|
SECONDARY outcome
Timeframe: 1-year after hospital dischargeOutcome measures
| Measure |
RBCT Based on rSO2 Value
n=46 Participants
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
n=51 Participants
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Long-term Mortality
|
12 participants
|
12 participants
|
SECONDARY outcome
Timeframe: At hospital discharge, an average of 21 daysGOS measures the degree of disability associated with the brain injury Unfavorable GOS included the categories of: 1. death. 2. vegetative status. 3. severe disability.
Outcome measures
| Measure |
RBCT Based on rSO2 Value
n=46 Participants
Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
RBCT Based on Hemoglobin Level Value
n=51 Participants
Intervention: In the hemoglobin - strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.
Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)
|
|---|---|---|
|
Unfavorable Glasgow Outcome Scale (GOS)
|
27 participants
|
36 participants
|
Adverse Events
RBCT Based on rSO2 Value
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RBCT Based on Hemoglobin Level Value
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Santiago R Leal-Noval, MD, PhD
University Hospital "Virgen del Rocío"
Phone: 0034954012528
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place