Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University

Criteria

Inclusion Criteria:

• Stable, compliant, chronically transfused sickle cell disease (SCD) patients

• Currently maintained crisis-free with repeated RBC therapy for at least 3 consecutive sessions

• ≥18 years old

• Have Hb SS disease

• Have the capacity to give informed consent

Exclusion Criteria:

• Baseline need for washed RBCs

• Pre-treatment SaO2 < 92%.