Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Anemia Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT00651573
• Study type: Interventional
• Source: The Cleveland Clinic
• Status: Completed
• Phase: N/A
• Start date: March 2007
• Completion date: January 3, 2019