NCT03364686

Transfusion of Biotin-Labeled Red Blood Cells

Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage and Post-Transfusion Red Blood Cell Recovery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Gladwin, Mark, MD · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research is to evaluate the impact of genetic and biologic factors in blood donors on red blood cell storage stability after autologous transfusion over the different range of storage period of 5-7 days and 35-42 days in healthy volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Biotin-Labeled Red Blood Cells	We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage).

Timeline

• Start date: 2019-09-16
• Primary completion: 2021-03-02
• Completion: 2021-06-29
• First posted: 2017-12-06
• Last updated: 2022-04-21
• Results posted: 2022-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study