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Red Cell Storage Duration and Outcomes in Cardiac Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00458783
First Posted: April 11, 2007
Last Update Posted: April 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
April 9, 2007
April 11, 2007
April 18, 2017
April 2007
December 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. ]
Not Provided
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
  • 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.
 
Active, not recruiting
2800
December 2017
December 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00458783
07-140
Yes
Not Provided
Plan to Share IPD: No
The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Joseph Sabek, MD The Cleveland Clinic
The Cleveland Clinic
April 2017

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