Red Cell Storage Duration and Outcomes in Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
d sessler, Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00458783
First received: April 9, 2007
Last updated: February 27, 2016
Last verified: February 2016
  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
Biological: Prolonged RBC storage
Biological: Short RBC storage

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 The Cleveland Clinic:

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 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prolonged RBC storage
Transfusion with oldest available matching RBCs.
Biological: Prolonged RBC storage
Transfusion with oldest available matching RBCs
Active Comparator: Short RBC storage
Transfusion with youngest available matching RBCs.
Biological: Short RBC storage
Transfusion with youngest available matching RBCs

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: Cuko Evis, MD 216-445-0998 cukoe@ccf.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: d sessler, Chairman of Outcomes Research, Outcomes Research Consortium
ClinicalTrials.gov Identifier: NCT00458783     History of Changes
Other Study ID Numbers: 07-140 
Study First Received: April 9, 2007
Last Updated: February 27, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Transfusion
Cardiac
Blood storage duration

ClinicalTrials.gov processed this record on May 23, 2016