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

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.

Inclusion Criteria:

• Ages 18 years and older
• Weight ≥110 lbs
• Hemoglobin ≥ 12.5 g/dL or hematocrit ≥ 38% for women and hemoglobin ≥ 13.0 g/dL or hematocrit ≥ 39% for men.
• Meet criteria for autologous blood donation

Exclusion Criteria:

• Subjects with a past medical history or symptoms of blood dyscrasia, diabetes mellitus, hyperlipidemia, obstructive sleep apnea, renal disease, congestive heart failure, significant cardiac disease and / or known peripheral arterial disease.
• Moderate to severe systemic hypertension (systolic blood pressure >140 mmHg and/or diastolic blood pressure > 95 mmHg
• Systolic blood pressure <100 mmHg and/or diastolic blood pressure < 60 mmHg on the study day.
• Positive Direct Antiglobulin Test
• Consumption of biotin supplements or raw eggs within 30 days
• Treatment with antibiotics in the week before initiating study participation to avoid suppression of erythropoiesis, which may accompany infection.
• Blood loss in the previous 8 weeks due to epistaxis, trauma, hemoptysis, gastrointestinal bleeding, diagnostic phlebotomy (> 30 ml)
• Subjects who report tobacco or marijuana smoking within 6 months of study.
• Cognitively impaired subjects, or institutionalized persons and subjects unable or unwilling to complete written informed consent
• Subjects with a history of blood donation within the last 56 days.
• Use of other investigational drugs/devices within 30 days of screening.
• Subjects taking any medication for the treatment of diabetes including insulin
• Females of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on screening day will be excluded.
• History of prior transfusion reaction to blood products.
• Allergic reaction to biotin
• Donors with naturally occurring antibodies against BioRBCs will be excluded from the study