Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Summary

The objective of this proposal is to test the feasibility of red blood cell (RBC) rejuvenation to chronic transfusion in sickle cell disease (SCD) and the potential benefit of RBC rejuvenation in this population to determine if a larger clinical trial powered to definitively characterize the benefits of rejuvenation is warranted. This is a small pilot study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to individuals over standard blood transfusion. Subjects will receive either rejuvenated (R) or standard (S) RBCs with each transfusion for 6 transfusions (over approximately a 6-month period) in a pre-defined order to maximize detection of any signal.

Timeline

Start

2016-12

Primary completion

2017-12-31

Completion

2017-12-31

Outcome

Missed primary endpoint

registry analysis (other test); Transfusion With Rejuvenated Red Blood Cells (RBCs) vs Transfusion With Standard Red Blood Cells; p = 0.95; Mean Difference (Final Values) 0.65; ANOVA NCT02731157 ↗

Drugs

Indications