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Sponsored by: |
Outcomes Research Consortium |
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Information provided by: | Outcomes Research Consortium |
ClinicalTrials.gov Identifier: | NCT00651573 |
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
Condition | Intervention |
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Cardiac Surgery |
Procedure: Blood transfusion |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Controlled Trial of Transfusion Strategies in Cardiac Surgery |
Estimated Enrollment: | 1300 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
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 25%,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 25%, no further transfusions will be administered.
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Procedure: Blood transfusion
transfusion
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2: Active Comparator
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 85%, no further transfusions will be administered.
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Procedure: Blood transfusion
transfusion
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Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value.
Hematocrit Groups:
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 2, 4, 6, and 12 weeks after surgery to ask the same questions.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ivan Parra Sanchez, MD | 26-445-4271 | parrai@ccf.org |
Contact: Nancy Graham, BA,CCRP | 216-445-7530 | grahamn@ccf.org |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Hyndhavi Chowdary, MD 216-445-9857 chowdah@ccf.org | |
Contact: Nancy Graham, BA,CCRP 216-445-7530 grahamn@ccf.org |
Study Chair: | Daniel I Sessler, MD | Cleveland Clinic |
Principal Investigator: | Colleen Koch, MD | Cleveland Clinic |
Responsible Party: | Cleveland Clinic ( Colleen Koch, MD ) |
Study ID Numbers: | 08-064 |
Study First Received: | March 31, 2008 |
Last Updated: | August 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00651573 |
Health Authority: | United States: Institutional Review Board |
Surgery Cardiopulmonary bypass Coronary artery bypass graft |
Valve procedure Hematocrit level Outcomes |