Impact of Blood Storage Duration on Physiologic Measures

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