Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions

Phase 4

Completed

Conditions: Sickle Cell Disease

Interventions: Drug: Rejuvesol
Procedure: Blood transfusion

Registration Number: NCT02731157

Lead Sponsor: Duke University

Brief 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.

Detailed Description: Blood transfusion is part of the standard care for individuals that have sickle cell disease. Often these transfusions become needed quite frequently. The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. People with sickle cell disease have abnormal red blood cells. Stored blood undergoes some changes that may make it less effective in achieving this goal.

The purpose of this 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. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to individuals who need frequent transfusions. Potential advantages include better delivery of oxygen by the transfused red blood cells and easier release of oxygen to the tissues. In addition the study will assess how using the rejuvenated blood affects the interval between transfusions. This means possibly that transfusions may not be needed as often.

Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to individuals who have sickle cell disease. Use of Rejuvesol in this study is considered investigational.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 4

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%.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transfusion with rejuvenated red blood cells (RBCs)	Rejuvesol	Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
Transfusion with rejuvenated red blood cells (RBCs)	Blood transfusion	Subjects with sickle cell disease will receive RBCs treated with Rejuvesol®. Scheduled red cell exchanges performed with the last 4 units of the exchange having been incubated with Rejuvesol® solution. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
Transfusion with standard red blood cells	Blood transfusion	Subjects with sickle cell disease will receive standard RBCs. Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.

Primary Outcome Measures

Name	Time	Method
Average Percent Hemoglobin (HbA) Decrement Per Day	6 months	The %HbA decrement is the current pre-treatment HbA - previous post treatment HbA in %. The average %HbA decrement per day was calculated using matched pairs.

Secondary Outcome Measures

Name	Time	Method
Actual HbA Decrement (g/dl) With Indexing to Calculated Circulating Blood Volume	6 months
Actual HbA Decrement (g/dl) Without Indexing to Calculated Circulating Blood Volume	6 months
Change in p50 Pre- and Post-transfusion	6 months
Change in RBC/RBC-MP-mediated Thrombin Generation	6 months
Change in RBC Microparticles (MP) Counts	6 months

Trial Locations

Locations (2): Duke Univeristy Medical Center
🇺🇸
Durham, North Carolina, United States
University of North Carolina at Chapel Hill
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Chapel Hill, North Carolina, United States