Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Completed · Phase 4

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT02731157

Run by

Duke University

People needed

4

Starts

2016-12-01

Expected to finish

2017-12-31

Last updated by the study team

2019-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Baseline need for washed RBCs
• Pre-treatment SaO2 < 92%.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke Univeristy Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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