Transfusion of Biotinylated Red Blood Cells — b-RBCs  

Anemia Clinical Trial

Official title: RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival

Status Completed

Clinical Trial 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.

Clinical Trial Description

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.

In this study, blood is collected from healthy subjects, processed into packed red blood cell units, and either immediately afterwards or 40-42 days later the packed red blood cells are labeled with biotin. The biotin-labeled red blood cells are then re-infused back to the donor (autologous transfusion). Blood samples are then taken from the subject every week for up to 70 days (10 weeks) to track survival of the labeled red blood cells.

This study also seeks to demonstrate that biotin-labeled RBCs can be safely transfused back to autologous subjects without any adverse reactions. All participants will be followed to watch for the development of antibodies against biotin-labeled RBCs. ;

Related Conditions & MeSH terms

• Anemia

• NCT number: NCT02757898
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2017
• Completion date: November 13, 2018