Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Study Overview
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Brief Summary
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The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery. The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.

Detailed Description
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Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value. Hematocrit Groups: 24% 28% Red blood cell transfusion will be given only when hematocrit values fall below the assigned group value. When the hematocrit value falls to a value less than the value for the randomized group a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to the randomized group no further transfusions will be administered. A measurement of the patient's HCT after each unit of RBC administered is required prior to administering additional units. If a patient's hematocrit is greater than the value for the group which they are randomized, no transfusion of RBC is necessary. Other management decisions are left up to the discretion of the care team. Adherence to the treatment protocol will be required for the patients in the operating room, intensive care unit and postoperatively until discharge from the hospital. Before surgery, the patient will be asked to respond to a quality-of-life questionnaire. Follow up phone calls will be made by Study personnel at 1 and 3 months after surgery to ask the same questions.

Official Title
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Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Conditions
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Anemia

Intervention / Treatment
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* Procedure: Blood transfusion at hematocrit value less than 24%
* Procedure: Blood transfusion at hematocrit value less than 28%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All primary and reoperative adult cardiac surgical patients undergoing cardiopulmonary bypass for coronary artery bypass grafting, coronary artery bypass grafting with a valve procedure, isolated valve procedures and ascending aortic repair for aneurysm or dissection procedures. Exclusion Criteria: Age less than 18 years Congenital procedures Emergencies descending thoracic aortic aneurysm repairs Left or right ventricular assist devices Left ventricular aneurysm resections Heart or lung transplantation Those unable to receive blood for religious reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blood transfusion triggers of 24% hematocrit value<br>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 HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 24%, no further transfusions will be administered. | Procedure: Blood transfusion at hematocrit value less than 24%<br>* transfusion<br>|
| Active Comparator: Blood transfusion triggers of 28% hematocrit value<br>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 HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to 28%, no further transfusions will be administered. | Procedure: Blood transfusion at hematocrit value less than 28%<br>* transfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Composite of In-hospital Postoperative Morbidity and Mortality | 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). | After surgery until hosptal discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU Stays |  | After surgery until discharged from ICU | 
| Length of Hospital Stay |  | After surgery until hospital discharge | 
| Number of Blood Transfusion |  | From induction to the end of sugery | 
| Prolonged Postoperative Ventilation | On ventilation >24 hours after surgery | After surgeyr until hospital discharge | 
| Postoperative Atrial Fibrillation |  | After surgery until hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Outcomes, Surgery, Cardiopulmonary bypass, Coronary artery bypass graft, Valve procedure, Hematocrit level