Transfusion of Biotin-Labeled Red Blood Cells
Condition: Healthy Volunteers
Intervention: Biotin-Labeled Red Blood Cells
Intervention description: We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage).
Intervention MeSH terms: Biotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BioRBCs; Biotin labeled red blood cells

Summary:

      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.
    

Eligibility criteria:

        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