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NCT00731588 · ClinicalTrials.gov registry record · Phase 2
Red Blood Cell (RBC) Survival Following Transfusion in Infants
A Phase 2 study, sponsored by John A Widness.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
NCT00731588: Completed Phase 2 study, sponsored by John A Widness.
NCT00731588 is a Phase 2 study that has completed, run by John A Widness. The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00731588, a Phase 2 study, has completed, sponsored by John A Widness.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
Study Summary
OUR OVERALL HYPOTHESIS is that post-transfusion survival of allogeneic and autologous RBCs can be accurately quantified in anemic human infants using biotin-labeled RBCs combined with mathematical modeling that adjusts for confounding factors commonly encountered in neonates. These confounding factors include 1) dilution of labeled RBC as a result of growth stimulated erythropoiesis, anemia stimulated erythropoiesis, and blood transfusion; 2) loss of labeled RBC due to laboratory phlebotomy; and 3) variable RBC life spans resulting from RBCs having been produced at different developmental periods and under varying rates of erythropoiesis. In contrast to infants, adjustment for these factors is not necessary in healthy adults under conditions of steady state erythropoiesis. Instead in adults, RBC survival is typified by a linear decline in concentration of labeled RBCs over time. When this line is extrapolated to zero concentration, the intercept with the time axis represents the mean potential lifespan (MPL) of RBCs. (\<7 d) and stored (\>21 d) allogeneic adult RBCs transfused in the same infant.
Primary Outcome
The biotin-labeled RBCs that were studied were: 2, 6, 18, 54, and 162 µg NHS-biotinylating reagent per mL of packed RBCs. Here we report the number of discrete biotin densities without overlap as determined in vitro.
Interventions
- BIOLOGICAL Transfused Biotin RBCs - Adults Phase I
- BIOLOGICAL Transfused Biotin RBCs - Infants Phase II
- BIOLOGICAL Transfused Biotin RBCs - Infants Phase III
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2008-06 |
| Est. Completion | 2018-03-02 |
| Phase | Phase 2 |
What the finished NCT00731588 record still lists
NCT00731588 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Transfused Biotin RBCs - Adults Phase I is the first listed.
NCT00731588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00731588 about?
NCT00731588 is a clinical study titled "Red Blood Cell (RBC) Survival Following Transfusion in Infants". OUR OVERALL HYPOTHESIS is that post-transfusion survival of allogeneic and autologous RBCs can be accurately quantified in anemic human infants using biotin-labeled RBCs combined with mathematical modeling that adjusts for confounding factors commonly encountered in neonates. These confounding facto...
What is the current status of trial NCT00731588?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2008-06. Estimated completion is 2018-03-02.
What interventions are being tested in trial NCT00731588?
The interventions under investigation include: Transfused Biotin RBCs - Adults Phase I (BIOLOGICAL), Transfused Biotin RBCs - Infants Phase II (BIOLOGICAL), Transfused Biotin RBCs - Infants Phase III (BIOLOGICAL).
Who is sponsoring clinical trial NCT00731588?
This trial is sponsored by John A Widness, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00731588's enrollment target sits among peer trials
140 512th of 2000 higher than 1,476 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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