Trial Outcomes & Findings for Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery (NCT NCT00651573)
NCT ID: NCT00651573
Last Updated: 2019-06-14
Results Overview
The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation \[\>24 hours\]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
722 participants
Primary outcome timeframe
After surgery until hosptal discharge
Results posted on
2019-06-14
Participant Flow
Participant milestones
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
|---|---|---|
|
Overall Study
STARTED
|
365
|
357
|
|
Overall Study
COMPLETED
|
363
|
354
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
n=363 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
n=354 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
Total
n=717 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 15 • n=363 Participants
|
60 years
STANDARD_DEVIATION 13 • n=354 Participants
|
60 years
STANDARD_DEVIATION 14 • n=717 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=363 Participants
|
121 Participants
n=354 Participants
|
254 Participants
n=717 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=363 Participants
|
233 Participants
n=354 Participants
|
463 Participants
n=717 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
123 participants
n=363 Participants
|
112 participants
n=354 Participants
|
235 participants
n=717 Participants
|
|
Region of Enrollment
India
|
240 participants
n=363 Participants
|
242 participants
n=354 Participants
|
482 participants
n=717 Participants
|
|
Hematocrit
|
37.1 volume percentage of red blood cells
n=363 Participants
|
38.0 volume percentage of red blood cells
n=354 Participants
|
37.6 volume percentage of red blood cells
n=717 Participants
|
|
Serum creatinine
|
0.87 mg/dL
n=363 Participants
|
0.87 mg/dL
n=354 Participants
|
0.87 mg/dL
n=717 Participants
|
PRIMARY outcome
Timeframe: After surgery until hosptal dischargeThe composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation \[\>24 hours\]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia).
Outcome measures
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
n=363 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
n=354 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
|---|---|---|
|
A Composite of In-hospital Postoperative Morbidity and Mortality
|
59 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: After surgery until discharged from ICUOutcome measures
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
n=363 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
n=354 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
|---|---|---|
|
Length of ICU Stays
|
67 hours
Interval 56.0 to 86.0
|
66 hours
Interval 59.0 to 72.0
|
SECONDARY outcome
Timeframe: After surgery until hospital dischargeOutcome measures
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
n=363 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
n=354 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
|---|---|---|
|
Length of Hospital Stay
|
10 days
Interval 8.0 to 11.0
|
10 days
Interval 8.0 to 11.0
|
SECONDARY outcome
Timeframe: From induction to the end of sugeryOutcome measures
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
n=363 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
n=354 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
|---|---|---|
|
Number of Blood Transfusion
|
1 times
Interval 0.0 to 2.0
|
1 times
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: After surgeyr until hospital dischargeOn ventilation \>24 hours after surgery
Outcome measures
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
n=363 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
n=354 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
|---|---|---|
|
Prolonged Postoperative Ventilation
|
22 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: After surgery until hospital dischargeOutcome measures
| Measure |
Blood Transfusion Triggers of 24% Hematocrit Value
n=363 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 24%. When the hematocrit value falls to less 24%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered.
|
Blood Transfusion Triggers of 28% Hematocrit Value
n=354 Participants
Red blood cell transfusion will be given when hematocrit values fall below the assigned group 1 value which is 28%. When the hematocrit value falls to less 28%, a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat hematocrit test is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered.
|
|---|---|---|
|
Postoperative Atrial Fibrillation
|
33 Participants
|
45 Participants
|
Adverse Events
Blood Transfusion Triggers of 24% Hematocrit Value
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Blood Transfusion Triggers of 28% Hematocrit 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place