Clinical trial NCT01274390: Impact of Blood Storage Duration on Physiologic Measures
Official title: Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Erythrocyte Transfusion
Keywords: Cardiac Surgery
Red Blood Cell
Transfusion
Oxygen Saturation
Microvascular Flow
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-01-11
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals

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


Eligibility 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

Primary outcomes:
measure: Change in thenar oxygenation saturation
timeFrame: 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:
measure: Change in downslope of thenar oxygen saturation
timeFrame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
measure: Change in upslope of thenar oxygen saturation
timeFrame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
measure: Change in cerebral oxygenation
timeFrame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
measure: Change in microvascular mean flow index
timeFrame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
measure: Change in percent perfused vessels
timeFrame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
measure: Change in capillary density index
timeFrame: From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion.
measure: Change in thenar oxygen saturation
timeFrame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
measure: Change in downslope of thenar oxygen saturation
timeFrame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
measure: Change in upslope of thenar oxygen saturation
timeFrame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
measure: Change in cerebral oxygenation
timeFrame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
measure: Change in microvascular mean flow index
timeFrame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
measure: Change in percent perfused vessels
timeFrame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
measure: Change in capillary density index
timeFrame: From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
measure: Change in multi-organ dysfunction score
timeFrame: From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first
measure: All-cause mortality
timeFrame: Through post-operative Day 28
measure: Composite of major cardiac events
timeFrame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first
measure: Composite of major pulmonary events
timeFrame: Through post-operative Day 7, hospital discharge, or death, whichever occurs first
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Womens Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Elliott Bennett-Guerrero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Christopher Stowell, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.