Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

This study is currently recruiting participants.
Verified December 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Colleen Koch, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00651573
First received: March 31, 2008
Last updated: December 4, 2013
Last verified: December 2013
  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
Focus- Optimal HCT to Balance Anemia and RBC.
Procedure: Blood transfusion at hematocrit value less than 25%
Procedure: Blood transfusion at hematocrit value less than 28%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 28%
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 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651573

Contacts
Contact: Jinbo Liu, MD 216-445-4289 liuj6@ccf.org
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org

Locations
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   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00651573     History of Changes
Other Study ID Numbers: 08-064
Study First Received: March 31, 2008
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 22, 2014