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NCT06788080 · ClinicalTrials.gov registry record · Early Phase 1
Optimization of Biotinylation Protocol for Studies of Red Blood Cell Survival and Function After Transfusion
A Early Phase 1 study, sponsored by Vitalant Research Institute.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT06788080: Completed Early Phase 1 study, sponsored by Vitalant Research Institute.
NCT06788080 is a Early Phase 1 study that has completed, run by Vitalant Research Institute. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06788080, a Early Phase 1 study, has completed, sponsored by Vitalant Research Institute.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to compare two methods of labeling red blood cells with biotin. The main question to answer is whether red blood cells labeled 48 hours before transfusion survive as long as red blood cells labeled 6 hours before transfusion. Secondary questions are to measure the quality of the red blood cells and whether or not the biotin-labeled red blood cells induce antibodies in transfusion recipients. This study participant will have six study visits: 1. Screening visit, collect 35 ml blood, about 3 tablespoons 2. Donate 500 ml blood 3. Receive 20 ml of biotin labeled blood transfusion, collect 40 ml blood, about 3 tablespoons 4. Return 1 day after transfusion for blood draw (25 ml, about 2 tablespoons) 5. Return 30 days after transfusion for blood draw (25 ml, about 2 tablespoons) 6. Return 90 days after transfusion for blood draw (25 ml, about 2 tablespoons)
Primary Outcome
The percent recovery of BioRBCs (the percentage of infused BioRBCs remaining in circulation) labeled 48 hours vs. 6 hours prior to transfusion will be tested in each participant. Recovery will be compared between BioRBCs labeled at 6 vs. 48 hours.
Interventions
- DRUG BioRBC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2024-11-04 |
| Phase | Early Phase 1 |
What the finished NCT06788080 record still lists
NCT06788080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which BioRBC is the first listed.
NCT06788080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06788080 about?
NCT06788080 is a clinical study titled "Optimization of Biotinylation Protocol for Studies of Red Blood Cell Survival and Function After Transfusion". The goal of this clinical trial is to compare two methods of labeling red blood cells with biotin. The main question to answer is whether red blood cells labeled 48 hours before transfusion survive as long as red blood cells labeled 6 hours before transfusion. Secondary questions are to measure the ...
What is the current status of trial NCT06788080?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2024-03-07. Estimated completion is 2024-11-04.
What interventions are being tested in trial NCT06788080?
The interventions under investigation include: BioRBC (DRUG).
Who is sponsoring clinical trial NCT06788080?
This trial is sponsored by Vitalant Research Institute, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06788080's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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