Transfusion of Biotinylated Red Blood Cells
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/4/2018 |
| Start Date: | April 2016 |
| End Date: | January 2020 |
| Contact: | John D Roback, MD, PhD |
| Email: | jroback@emory.edu |
| Phone: | 404-712-1774 |
RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival
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.
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.
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.
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.
Inclusion Criteria:
- in good health
Exclusion Criteria:
- anemia (defined as hemoglobin < 8 g/dL)
- chronic disease, including diabetes, heart or lung disease, poorly managed
hypertension, and peripheral vascular disease
- ongoing consumption of biotin or raw egg supplements
- history of a bleeding disorder
- evidence of anemia at initial screening
- women who are pregnant or plan to become pregnant
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