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

April 9, 2007
February 27, 2016
April 2007
February 2017   (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
  • Biological: Prolonged RBC storage
    Transfusion with oldest available matching RBCs
  • Biological: Short RBC storage
    Transfusion with youngest available matching RBCs
  • Active Comparator: Prolonged RBC storage
    Transfusion with oldest available matching RBCs.
    Intervention: Biological: Prolonged RBC storage
  • Active Comparator: Short RBC storage
    Transfusion with youngest available matching RBCs.
    Intervention: Biological: Short RBC storage
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 2017
February 2017   (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   (Adult, Senior)
No
Contact: Cuko Evis, MD 216-445-0998 cukoe@ccf.org
Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org
United States
 
NCT00458783
07-140
Yes
No
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d sessler, Outcomes Research Consortium
The Cleveland Clinic
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Principal Investigator: Joseph Sabek, MD The Cleveland Clinic
The Cleveland Clinic
February 2016

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