Eligibility Details:
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