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Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00651573
Recruitment Status : Active, not recruiting
First Posted : April 3, 2008
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Anemia Procedure: Blood transfusion at hematocrit value less than 25% Procedure: Blood transfusion at hematocrit value less than 28%

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 717 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery
Study Start Date : March 2007
Primary Completion Date : August 2014
Estimated Study Completion Date : December 2017

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 28%
transfusion


Outcome Measures

Primary Outcome Measures :
  1. hematocrit values [ Time Frame: post-induction, first few seconds ]
    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.

  2. hematocrit values [ Time Frame: every 20 minutes ]
    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.

  3. hematocrit values [ Time Frame: Post cardiopulmonary bypass, first few seconds ]
    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.

  4. hematocrit values [ Time Frame: pre-induction, first few seconds ]
    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.

  5. hematocrit values [ Time Frame: in ICU, daily ]
    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.


Secondary Outcome Measures :
  1. health-related quality of life following surgery. [ Time Frame: 12 weeks after patient's surgery ]
    The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651573


Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
India
S.A.L. Hospital and Medical Institute
Ahmedabad, Thaltej,, India, 380054
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
Principal Investigator: Daniel I Sessler, MD The Cleveland Clinic
More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00651573     History of Changes
Other Study ID Numbers: 08-064
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017

Keywords provided by The Cleveland Clinic:
Surgery
Cardiopulmonary bypass
Coronary artery bypass graft
Valve procedure
Hematocrit level
Outcomes