Clinical trial NCT00651573: Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
Official title: Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Keywords: Surgery
Cardiopulmonary bypass
Coronary artery bypass graft
Valve procedure
Hematocrit level
Outcomes
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-04-03
Enrollment: 722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: A Composite of In-hospital Postoperative Morbidity and Mortality
timeFrame: After surgery until hosptal discharge
Secondary outcomes:
measure: Length of ICU Stays
timeFrame: After surgery until discharged from ICU
measure: Length of Hospital Stay
timeFrame: After surgery until hospital discharge
measure: Number of Blood Transfusion
timeFrame: From induction to the end of sugery
measure: Prolonged Postoperative Ventilation
timeFrame: After surgeyr until hospital discharge
measure: Postoperative Atrial Fibrillation
timeFrame: After surgery until hospital discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Ahmedabad
country: India
facility: S.A.L. Hospital and Medical Institute
state: Thaltej,
Study officials:
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.