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NCT02731157 · ClinicalTrials.gov registry record · Phase 4
Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions
A Phase 4 study, sponsored by Duke University.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT02731157: Completed Phase 4 study, sponsored by Duke University.
NCT02731157 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02731157, a Phase 4 study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Rejuvesol
- PROCEDURE Blood transfusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-12 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 4 |
What the finished NCT02731157 record still lists
NCT02731157 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Rejuvesol is the first listed.
NCT02731157 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02731157 about?
NCT02731157 is a clinical study titled "Rejuvesol® Washed RBC in Sickle Cell Patients Requiring Frequent Transfusions". 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 benefit...
What is the current status of trial NCT02731157?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2016-12. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT02731157?
The interventions under investigation include: Rejuvesol (DRUG), Blood transfusion (PROCEDURE).
Who is sponsoring clinical trial NCT02731157?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02731157's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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