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Red Blood Cell 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 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.
Details
| Lead sponsor | John A Widness |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 140 |
| Start date | 2008-06 |
| Completion | 2018-03-02 |
Conditions
- Neonatal Anemia
Interventions
- Transfused Biotin RBCs - Adults Phase I
- Transfused Biotin RBCs - Infants Phase II
- Transfused Biotin RBCs - Infants Phase III
Primary outcomes
- Number of Discrete Biotinylated RBC Densities (up to 5 Discrete Densities) That Can be Accurately Measured by Flow Cytometry, i.e., Without Overlap. — from day of blood draw this can be accomplished in 4 hours
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. - RBC Survival (Life Span) in Days of Multiple, Distinct BioRBC Density Populations of Transfused Autologous RBCs in Adults and Premature Infants. — for up to 5 months
Using flow cytometry was measured for each RBC biotin density in days as determined when RBC measurement was no longer detectable. - RBC Survival (Life Span) in Days of Multiple, Distinct BioRBC Density Populations of Transfused Allogeneic RBCs in Premature Infants. — for up to 4 months
Using flow cytometry was measured for each RBC biotin density in days as determined when RBC measurement was no longer detectable.
Countries
United States