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

April 9, 2007
January 28, 2013
April 2007
February 2014   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00458783 on ClinicalTrials.gov Archive Site
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Red Cell Storage Duration and Outcomes in Cardiac Surgery
Red Cell Storage Duration and Outcomes in Cardiac Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
  • Blood Transfusion
  • Cardiac Surgery
  • Procedure: Blood transfusion
    Red blood cell transfusion with a storage duration of less than 14 days.
  • Procedure: Blood transfusion
    Blood transfusion during cardiac surgery with blood storage duration of more than 20 days.
  • Active Comparator: red blood cells stored longer than 20 days
    Red blood cell transfusion with blood cell storage duration more than 20 days.
    Intervention: Procedure: Blood transfusion
  • Active Comparator: red blood cells stored less than 14 days
    Red blood cell transfusion with blood cell storage duration less than 14 days.
    Intervention: Procedure: Blood transfusion
Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2800
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Babak Kashy, MD 216-445-0998 kashyb@ccf.org
Contact: Gretchen Upton 216-444-3289 uptong@ccf.org
United States
 
NCT00458783
07-140
Yes
Colleen Koch, Outcomes Research Consortium
Outcomes Research Consortium
Not Provided
Principal Investigator: Colleen G Koch, MD MS The Cleveland Clinic
Outcomes Research Consortium
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP