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
  Purpose

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

Condition Phase
Cardiac Surgery
Erythrocyte Transfusion
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 390
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274390

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Elliott Bennett-Guerrero, MD Duke University
Principal Investigator: Christopher Stowell, MD, PHD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01274390     History of Changes
Other Study ID Numbers: Pro00021198, R01HL101382
Study First Received: January 9, 2011
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Duke University:
Cardiac Surgery
Red Blood Cell
Transfusion
Oxygen Saturation
Microvascular Flow

ClinicalTrials.gov processed this record on October 16, 2014