Phase 4
N=4
Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
Sickle Cell Disease
Bottom Line
View on ClinicalTrials.gov: NCT02731157 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Average Percent Hemoglobin (HbA) Decrement Per Day — 0.629; 0.659 %HbA per day — p=0.95
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rejuvesol (Drug); Blood transfusion (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Percent Hemoglobin (HbA) Decrement Per Day |
0.629; 0.659 | 0.95 |
| SECONDARY Actual HbA Decrement (g/dl) With Indexing to Calculated Circulating Blood Volume |
— | — |
| SECONDARY Actual HbA Decrement (g/dl) Without Indexing to Calculated Circulating Blood Volume |
— | — |
| SECONDARY Change in RBC Microparticles (MP) Counts |
— | — |
| SECONDARY Change in RBC/RBC-MP-mediated Thrombin Generation |
— | — |
| SECONDARY Change in p50 Pre- and Post-transfusion |
— | — |
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.
Eligibility 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%.
Data sourced from ClinicalTrials.gov (NCT02731157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.