Transfusion of Biotin-Labeled Red Blood Cells

Gladwin, Mark, MD

Status and phase

Terminated

Phase 2

Conditions

Healthy Volunteers

Treatments

Biological: Biotin-Labeled Red Blood Cells

Study type

Interventional

Funder types

NIH

Identifiers

NCT03364686

STUDY19020356

5R01HL098032-09 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts 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