Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery



Status:Active, not recruiting
Conditions:Cardiology, Anemia
Therapuetic Areas:Cardiology / Vascular Diseases, Hematology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 2007
End Date:December 2018

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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.

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.

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
We found this trial at
2
sites
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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Ahmedabad, Thaltej 38005
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