Impact of Blood Storage Duration on Physiologic Measures (RECAP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01274390
First received: January 9, 2011
Last updated: July 1, 2014
Last verified: July 2014

January 9, 2011
July 1, 2014
January 2011
January 2014   (final data collection date for primary outcome measure)
Change in thenar oxygenation saturation [ Time Frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01274390 on ClinicalTrials.gov Archive Site
  • Change in downslope of thenar oxygen saturation [ Time Frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. ] [ Designated as safety issue: No ]
  • Change in upslope of thenar oxygen saturation [ Time Frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. ] [ Designated as safety issue: No ]
  • Change in cerebral oxygenation [ Time Frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. ] [ Designated as safety issue: No ]
  • Change in microvascular mean flow index [ Time Frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. ] [ Designated as safety issue: No ]
  • Change in percent perfused vessels [ Time Frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. ] [ Designated as safety issue: No ]
  • Change in capillary density index [ Time Frame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. ] [ Designated as safety issue: No ]
  • Change in thenar oxygen saturation [ Time Frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery ] [ Designated as safety issue: No ]
  • Change in downslope of thenar oxygen saturation [ Time Frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery ] [ Designated as safety issue: No ]
  • Change in upslope of thenar oxygen saturation [ Time Frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery ] [ Designated as safety issue: No ]
  • Change in cerebral oxygenation [ Time Frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery ] [ Designated as safety issue: No ]
  • Change in microvascular mean flow index [ Time Frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery ] [ Designated as safety issue: No ]
  • Change in percent perfused vessels [ Time Frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery ] [ Designated as safety issue: No ]
  • Change in capillary density index [ Time Frame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery ] [ Designated as safety issue: No ]
  • Change in multi-organ dysfunction score [ Time Frame: From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: Through post-operative Day 28 ] [ Designated as safety issue: No ]
  • Composite of major cardiac events [ Time Frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
  • Composite of major pulmonary events [ Time Frame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Blood Storage Duration on Physiologic Measures
Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)

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:

  • Oxygen saturation in the hand
  • Oxygen saturation in the brain
  • Blood flow in the small blood vessels under the tongue.

The RECAP study will also investigate whether changes in the measurements listed above are associated with clinical outcomes, including

  • The Multi-Organ Dysfunction Score
  • Death from any cause
  • Major cardiac events
  • Major pulmonary events
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals

  • Cardiac Surgery
  • Erythrocyte Transfusion
Not Provided
  • Shorter-storage red blood cell units
    Red blood cell units stored <= 10 days
  • Longer-storage red blood cell units
    Red blood cell units stored >= 21 days
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible and randomized in the RECESS study (NCT00991341)
  • At least 18 years old
  • Willing to comply with protocol and provide written informed consent for both RECESS and RECAP
  • Scheduled to undergo coronary artery bypass (CABG), valve, or combined CABG plus valve surgery

Exclusion Criteria:

  • Prior randomization into the RECESS or RECAP studies
  • Undergoing off-pump cardiac surgery
  • Undergoing a significant concomitant surgical procedure
  • Known sickle cell disease
  • Participation in a clinical trial (except observational studies or RECESS) within the previous 30 days
  • Received any investigational product within prior 30 days
  • Not able to be randomized in RECESS
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01274390
Pro00021198, R01HL101382
Yes
Duke University
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Elliott Bennett-Guerrero, MD Duke University
Principal Investigator: Christopher Stowell, MD, PHD Massachusetts General Hospital
Duke University
July 2014

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