NCT01274390|CompletedDMC
Impact of Blood Storage Duration on Physiologic Measures
RECAP
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RECAP
Sponsor study identifier
Secondary identifiers
NIH
observational
390
1 country
4
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Study Completion
January 2014
Actual (reported)This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS study randomizes cardiac surgery patients to receive either red blood cell units stored for no more than 10 days, or red blood cell units stored for at least 21 days, if they need any red blood cell transfusions during their hospital stay for the surgery. This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there will be differences between the two randomized treatment groups in how much the following measurements change, from shortly before a red blood cell transfusion to shortly after a red blood cell transfusion, and from before surgery to 24 hours after surgery:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2011
Actual (reported)January 11, 2011
Actual (reported)January 2014
Actual (reported)January 2014
Actual (reported)Change in thenar oxygenation saturation
From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in downslope of thenar oxygen saturation
From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in upslope of thenar oxygen saturation
From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in cerebral oxygenation
From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in microvascular mean flow index
From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Change in percent perfused vessels
From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
Red blood cell units stored \<= 10 days
Red blood cell units stored \>= 21 days
Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Stowell CP, Whitman G, Granger S, Gomez H, Assmann SF, Massey MJ, Shapiro NI, Steiner ME, Bennett-Guerrero E. The impact of red blood cell storage duration on tissue oxygenation in cardiac surgery. J Thorac Cardiovasc Surg. 2017 Mar;153(3):610-619.e2. doi: 10.1016/j.jtcvs.2016.11.029. Epub 2016 Nov 19.
Elliott Bennett-Guerrero, MD
Duke University
Christopher Stowell, MD, PHD
Massachusetts General Hospital
First Submitted
January 9, 2011
First Posted
January 11, 2011
Study Start
January 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2014
Actual (reported)Rejuvenated RBC and VO2 Max in Healthy Subjects
Contact the study team to confirm eligibility.
Study Completion
January 2014
Actual (reported)Last Updated
February 2, 2017
Record last verified: 2014-07
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Source: ClinicalTrials.gov.
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