Impact of Blood Storage Duration on Physiologic Measures (RECAP)

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

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Erythrocyte Transfusion

• Study Type: Observational
• Enrollment (Anticipated): 390

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham and Womens Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Time Frame
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.
Change in capillary density 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 thenar oxygen saturation	From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
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
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 cerebral oxygenation	From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery
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 percent perfused vessels	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
Change in multi-organ dysfunction score	From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first
All-cause mortality	Through post-operative Day 28
Composite of major cardiac events	Through post-operative Day 7, hospital discharge, or death, whichever occurs first
Composite of major pulmonary events	Through post-operative Day 7, hospital discharge, or death, whichever occurs first

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Elliott Bennett-Guerrero, MD, Duke University; Principal Investigator: Christopher Stowell, MD, PHD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 9, 2011
• First Submitted That Met QC Criteria: January 9, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: February 1, 2017
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Red Blood Cell; Transfusion; Oxygen Saturation; Microvascular Flow
• Other Study ID Numbers: Pro00021198; R01HL101382 (U.S. NIH Grant/Contract)