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

Phase 1

Terminated

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Mirasol Illumination Dose #2	Mirasol System for Whole Blood.	Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs
Mirasol Illumination Dose #1	Mirasol System for Whole Blood.	Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs)
Mirasol Illumination Dose #3	Mirasol System for Whole Blood.	Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs

Primary Outcome Measures

Name	Time	Method
Red Blood Cell (RBC) Recovery	24-hour post autologous infusion of RBCs	The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.

Secondary Outcome Measures

Name	Time	Method
Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival	28-days post autologous infusion of RBCs	The objective of measuring 28-day survival was to identify the potential total lifespan of labeled RBCs in circulation. Normal, native RBCs remain in circulation for a maximum of approximately 120 days; by using the 51Cr half-life of approximately 28 days, and its elution rate from labeled RBCs, the survival of the labeled cells can be predicted.
Count of Participants With Serious Adverse Events (SAE)	28-days post autologous infusion of RBCs