NCT01274390

Impact of Blood Storage Duration on Physiologic Measures

Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 390 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-01-11
• Last updated: 2017-02-02

Locations

4 sites across 1 country: United States