Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
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Purpose
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 |
|---|---|
|
Cardiac Surgery |
Procedure: Blood transfusion at hematocrit value less than 25% Procedure: Blood transfusion at hematocrit value less than 25% |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) |
- hematocrit values [ Time Frame: post-induction, first few seconds ] [ Designated as safety issue: No ]The primary aim is to determine the optimal hematocrit for which transfusion of RBC units is indicated to minimize the detrimental effects of anemia or transfusion.
- hematocrit values [ Time Frame: every 20 minutes ] [ Designated as safety issue: No ]The primary aim is to determine the optimal hematocrit for which transfusion of RBC units is indicated to minimize the detrimental effects of anemia or transfusion.
- hematocrit values [ Time Frame: Post cardiopulmonary bypass, first few seconds ] [ Designated as safety issue: No ]The primary aim is to determine the optimal hematocrit for which transfusion of RBC units is indicated to minimize the detrimental effects of anemia or transfusion.
- hematocrit values [ Time Frame: pre-induction, first few seconds ] [ Designated as safety issue: No ]The primary aim is to determine the optimal hematocrit for which transfusion of RBC units is indicated to minimize the detrimental effects of anemia or transfusion.
- hematocrit values [ Time Frame: in ICU, daily ] [ Designated as safety issue: No ]The primary aim is to determine the optimal hematocrit for which transfusion of RBC units is indicated to minimize the detrimental effects of anemia or transfusion.
- health-related quality of life following surgery. [ Time Frame: 12 weeks after patient's surgery ] [ Designated as safety issue: No ]The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.
| Estimated Enrollment: | 1300 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
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.
|
Procedure: Blood transfusion at hematocrit value less than 25%
transfusion
|
|
Active Comparator: 2
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.
|
Procedure: Blood transfusion at hematocrit value less than 25%
transfusion
|
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:
- 24%
- 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jinbo Liu, MD | 216-445-4289 | liuj6@ccf.org |
| Contact: Gretchen Upton | 216-444-3289 | uptong@ccf.org |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Colleen Koch, MD 216-445-7418 kochc@ccf.org | |
| Contact: Gretchen Upton 216-905-3932 uptong@ccf.org | |
| India | |
| S.A.L. Hospital and Medical Institute | Recruiting |
| Ahmedabad, Thaltej,, India, 380054 | |
| Contact: Anil Jain +91-79-4005 4103 | |
| Contact: Dhruti Trivedi 91-79-4005 4103 hcaresearch.cvts@gmail.com | |
| Study Chair: | Daniel I Sessler, MD | The Cleveland Clinic |
| Principal Investigator: | Colleen Koch, MD | The Cleveland Clinic |
More Information
No publications provided
| Responsible Party: | Colleen Koch, Principal Investigator, Outcomes Research Consortium |
| ClinicalTrials.gov Identifier: | NCT00651573 History of Changes |
| Other Study ID Numbers: | 08-064 |
| Study First Received: | March 31, 2008 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Outcomes Research Consortium:
|
Surgery Cardiopulmonary bypass Coronary artery bypass graft |
Valve procedure Hematocrit level Outcomes |
ClinicalTrials.gov processed this record on June 18, 2013