Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

NeuroTherapia, Inc.

Status: Completed

Conditions: Anemia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00651573

08-064

Details and patient eligibility

About

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.

Full 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.

Enrollment: 722 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

722 participants in 2 patient groups

Blood transfusion triggers of 24% hematocrit value

Active Comparator group

Description:

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.

Treatment:

Procedure: Blood transfusion at hematocrit value less than 24%

Blood transfusion triggers of 28% hematocrit value

Active Comparator group

Description:

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.

Treatment:

Procedure: Blood transfusion at hematocrit value less than 28%