Impact of Blood Storage Duration on Physiologic Measures

Completed

• Conditions: Cardiac Surgery; Erythrocyte Transfusion

• Registration Number: NCT01274390
• Lead Sponsor: Duke University

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-09
• Study First Submitted QC: 2011-01-09
• Study First Posted: 2011-01-11
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-07
• Last Update Submitted: 2017-02-01
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States