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Transfusion of Biotinylated Red Blood Cells

NCT02757898 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-05-09

Study results available
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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.

Conditions

Interventions

DRUG

Biotin-Labeled Red Blood Cells (RBCs)

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Emory University

    lead OTHER

Principal Investigators

  • John D Roback, MD, PhD · Emory University

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-11
Primary Completion
2018-11-13
Completion
2018-11-13

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02757898 on ClinicalTrials.gov