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NCT06788080

Optimization of Biotinylation Protocol for Studies of Red Blood Cell Survival and Function After Transfusion

Completed EARLY_PHASE1 Last updated 22 January 2025
What this trial tests

EARLY_PHASE1 trial testing BioRBC in Measuring Red Blood Cell Survival After Transfusion in 12 participants. Completed in 4 November 2024.

Timeline
7 March 2024
Primary endpoint
4 November 2024
4 November 2024

Quick facts

Lead sponsorVitalant Research Institute
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment12
Start date7 March 2024
Primary completion4 November 2024
Estimated completion4 November 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Vitalant Research Institute

Who can join

18 and older, any sex, with Measuring Red Blood Cell Survival After Transfusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to compare two methods of labeling red blood cells with biotin. The main question to answer is whether red blood cells labeled 48 hours before transfusion survive as long as red blood cells labeled 6 hours before transfusion. Secondary questions are to measure the quality of the red blood cells and whether or not the biotin-labeled red blood cells induce antibodies in transfusion recipients. This study participant will have six study visits: 1. Screening visit, collect 35 ml blood, about 3 tablespoons 2. Donate 500 ml blood 3. Receive 20 ml of biotin labeled blood transfusion, collect 40 ml blood, about 3 tablespoons 4. Return 1 day after transfusion for blood draw (25 ml, about 2 tablespoons) 5. Return 30 days after transfusion for blood draw (25 ml, about 2 tablespoons) 6. Return 90 days after transfusion for blood draw (25 ml, about 2 tablespoons)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Optimization of biotinylation protocol for next generation studies of red blood cell survival after transfusion.
    Kanias T, George G, Sekiya J, Kelly K, et al · · 2025 · cited 4× · PMID 40390385 · DOI 10.1111/trf.18286

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06788080.

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