Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival

IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Radiolabeling of red blood cells (RBCs) followed by infusion back to the donor is commonly used to test the quality of RBCs in a person. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.

Inclusion Criteria:

• healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation
• females incapable of becoming pregnant
• males agreeing to use contraception during trial

Exclusion Criteria:

• pregnancy or nursing
• abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy)
• major surgery
• use of drugs affecting coagulation or RBC function
• recent participation in other trials which may confound results