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Impact of Blood Storage Duration on Physiologic Measures

NCT01274390 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 390

Last updated 2017-02-02

No results posted yet for this study

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

Conditions

  • Cardiac Surgery
  • Erythrocyte Transfusion

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Elliott Bennett-Guerrero, MD · Duke University

  • Christopher Stowell, MD, PHD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01274390 on ClinicalTrials.gov