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

NCT06788080 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-01-22

No results posted yet for this study

Summary

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)

Conditions

  • Measuring Red Blood Cell Survival After Transfusion

Interventions

DRUG

BioRBC

Autologous biotin-labeled RBCs will be transfused to study participants

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Vitalant Research Institute

    lead OTHER

Principal Investigators

  • Philip Norris, MD · Vitalant Research Institute

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2024-11-04
Completion
2024-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788080 on ClinicalTrials.gov