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Transfusion Strategies in Cardiac Surgery
This study is currently recruiting participants.
Verified by Outcomes Research Consortium, February 2009
Sponsored by: Outcomes Research Consortium
Information provided by: Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00651573
  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

MedlinePlus related topics: Blood Transfusion and Donation Heart Surgery Surgery
U.S. FDA Resources
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

Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • 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. [ Time Frame: During patient's hospitalization prior to, during and following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery. [ Time Frame: 12 weeks after patient's surgery ] [ Designated as safety issue: No ]

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
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.
Procedure: Blood transfusion
transfusion
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.
Procedure: Blood transfusion
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:

  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 2, 4, 6, and 12 weeks 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
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, and isolated valve procedures.

Exclusion Criteria:

  • Age less than 18 years
  • Congenital procedures
  • Emergencies
  • Ascending and 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651573

Contacts
Contact: Ivan Parra Sanchez, MD 26-445-4271 parrai@ccf.org
Contact: Nancy Graham, BA,CCRP 216-445-7530 grahamn@ccf.org

Locations
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    
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Study Chair: Daniel I Sessler, MD Cleveland Clinic
Principal Investigator: Colleen Koch, MD Cleveland Clinic
  More Information

Responsible Party: Cleveland Clinic ( Colleen Koch, MD )
Study ID Numbers: 08-064
Study First Received: March 31, 2008
Last Updated: February 4, 2009
ClinicalTrials.gov Identifier: NCT00651573  
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 February 11, 2009