At a glance
ClinicalIndex Comparison Record- ✓Participant must be in good health
- ✕Hemoglobin < 8 g/dL (anemia)
- ✕Chronic disease including diabetes, heart or lung disease, poorly managed hypertension, and peripheral vascular disease
- ✕Ongoing consumption of biotin or raw egg supplements
- ✕History of a bleeding disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival
In Brief
A Phase 1 clinical trial evaluating Biotin-Labeled Red Blood Cells (RBCs) for Anemia. Completed, enrolled 5 participants across 1 site.
Detailed Summary
The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. Investigators will study this by collecting blood samples from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will then be re-infused back into the participant and blood samples will be taken weekly for 10 weeks to assess the number of labeled cells in the samples.
Study Details
Timeline
Interventions
500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit. For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection. For participants 3 through 8, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant. Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs.