Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion
Jose Cancelas
Summary
This research is being done to compare the red blood circulation survival in healthy adult volunteers between the 51 chromium (51Cr) red blood cell (RBC) labeling method and the Biotin (BioRBC) red blood cell (RBC) labeling method to determine if biotinylated red blood cells (BioRBC) is an acceptable non radioactive alternative to 51 chromium (51Cr) radiolabeling for regulatory pharmacokinetic studies of red blood cell products.
Description
This is a Phase 1, randomized, controlled, autologous transfusion study in healthy adult volunteers designed to compare biotinylated red blood cells (BioRBC) with 51 chromium (51Cr)-labeled red blood cells for the assessment of red blood cell (RBC) recovery and survival after 42 days of storage, with and without irradiation at Day 0. Both 51Cr and biotin labeling have been used to measure autologous RBC recovery and survival, but biotin has not yet been accepted by the U.S. Food and Drug Administration (FDA) as a method to determine 24 hour post transfusion recovery and long term survival aft…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Signed and dated informed consent form. * Age ≥18 years, of either gender. * Normal health status (as determined by Investigators' review of medical history and physical exam). * Qualifies for a collection; Males: height \>5'1" and weight \>130 lbs; Females: height \>5' 5" and weight \> 150 lbs. * Complete blood count (CBC; including RBC indices MCV, MCH, MCHC, and RDW) and serum chemistry values within normal limits (including calcium, bicarbonate, chloride, inorganic phosphate, potassium, sodium, cholesterol, glucose, total protein, triglycerides, LDH, ALT, AS…
Interventions
- BiologicalBiotinylated Red Blood Cells (BioRBC)
Intravenous infusion
- BiologicalIrradiated Biotinylated Red Blood Cells (Irradiated BioRBC)
Intravenous infusion
- Biological51 Chromium Labeled Red Blood Cells (51Cr RBC)
Intravenous infusion
- BiologicalTechnetium 99m Labeled Red Blood Cells (99mTc RBC)
Intravenous infusion
Locations (2)
- Hoxworth Blood Center, University of CincinnatiCincinnati, Ohio
- American Red CrossNorfolk, Virginia