Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 390
- Locations
- 4
- Primary Endpoint
- Change in thenar oxygenation saturation
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in downslope of thenar oxygen saturation(From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery)
- All-cause mortality(Through post-operative Day 28)
- Change in cerebral oxygenation(From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery)
- Change in upslope of thenar oxygen saturation(From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery)
- Change in percent perfused vessels(From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery)
- Change in thenar oxygen saturation(From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery)
- Change in multi-organ dysfunction score(From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first)
- Composite of major cardiac events(Through post-operative Day 7, hospital discharge, or death, whichever occurs first)
- Change in microvascular mean flow index(From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery)
- Change in capillary density index(From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery)
- Composite of major pulmonary events(Through post-operative Day 7, hospital discharge, or death, whichever occurs first)