Phase 1
Completed N=5
Transfusion of Biotinylated Red Blood Cells
Source: ClinicalTrials.gov NCT02757898 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Number of Participants That Had bRBC Detectable at 70 Days Post-intervention — 5 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Had bRBC Detectable at 70 Days Post-intervention |
5 | — |
| PRIMARY Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another |
— | — |
| SECONDARY Number of Participants Experiencing Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- in good health
Exclusion Criteria
- anemia (defined as hemoglobin < 8 g/dL)
- 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
- evidence of anemia at initial screening
- women who are pregnant or plan to become pregnant
Data sourced from ClinicalTrials.gov (NCT02757898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.