Red Cell Storage Duration and Outcomes in Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Outcomes Research Consortium
Sponsor:
Information provided by (Responsible Party):
Colleen Koch, Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00458783
First received: April 9, 2007
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to determine whether length of storage of RBC is related to postoperative morbid outcomes in patients undergoing cardiac surgery.


Condition Intervention
Blood Transfusion
Cardiac Surgery
Procedure: Blood transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Red Cell Storage Duration and Outcomes in Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • Primary aim is to determine whether length of storage of Red Blood Cells is related to postoperative morbid outcomes in patients undergoing cardiac surgery. [ Time Frame: 30 days post surgery. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2800
Study Start Date: April 2007
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: red blood cells stored longer than 20 days
Red blood cell transfusion with blood cell storage duration more than 20 days.
Procedure: Blood transfusion
Blood transfusion during cardiac surgery with blood storage duration of more than 20 days.
Active Comparator: red blood cells stored less than 14 days
Red blood cell transfusion with blood cell storage duration less than 14 days.
Procedure: Blood transfusion
Red blood cell transfusion with a storage duration of less than 14 days.

Detailed Description:

Subjects undergoing cardiac surgery will be randomized into one of two groups. Group A will receive transfused blood that has storage duration less than 14 days. Group B will receive transfused blood with a storage duration of more than 20 days.

  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, ascending aortic aneurysm or dissection repair alone or combined with CABG and valve procedures

Exclusion Criteria:

  • Age less than 18 years
  • Descending thoracic aortic aneurysm repairs
  • Left or right ventricular assist devices
  • Those unable to receive blood for religious reasons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458783

Contacts
Contact: Babak Kashy, MD 216-445-0998 kashyb@ccf.org
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Colleen G Koch, MD MS         
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Colleen G Koch, MD MS The Cleveland Clinic
  More Information

No publications provided by Outcomes Research Consortium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Colleen Koch, Principal Investigator, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00458783     History of Changes
Other Study ID Numbers: 07-140
Study First Received: April 9, 2007
Last Updated: January 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
Transfusion
Cardiac
Blood storage duration

ClinicalTrials.gov processed this record on August 19, 2014