Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Not Applicable

Completed

Interventions: Procedure: Blood transfusion at hematocrit value less than 24%
Procedure: Blood transfusion at hematocrit value less than 28%

Brief Summary: 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: Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value.

Hematocrit Groups:

1. 24%

2. 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Blood transfusion triggers of 24% hematocrit value	Blood transfusion at hematocrit value less than 24%	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.
Blood transfusion triggers of 28% hematocrit value	Blood transfusion at hematocrit value less than 28%	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.

Primary Outcome Measures

Name	Time	Method
A Composite of In-hospital Postoperative Morbidity and Mortality	After surgery until hosptal discharge	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).

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	After surgery until hospital discharge
Number of Blood Transfusion	From induction to the end of sugery
Postoperative Atrial Fibrillation	After surgery until hospital discharge
Length of ICU Stays	After surgery until discharged from ICU
Prolonged Postoperative Ventilation	After surgeyr until hospital discharge	On ventilation \>24 hours after surgery