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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 is a Phase 4 study that has completed, run by Duke University. The registered enrollment target is 4 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02731157
The ClinicalTrials.gov registry entry for NCT02731157 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Rejuvesol is the first listed.
NCT02731157 reports 0 study locations.
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.
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