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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 is a Phase 2 study that has completed, run by John A Widness. The registered enrollment target is 140 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00731588
The ClinicalTrials.gov registry entry for NCT00731588 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John A Widness, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Transfused Biotin RBCs - Adults Phase I is the first listed.
NCT00731588 reports 0 study locations.
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.
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