Transfusion of Biotin-Labeled Red Blood Cells

Phase 2

Terminated

Conditions: Healthy Volunteers

Interventions: Biological: Biotin-Labeled Red Blood Cells

Registration Number: NCT03364686

Lead Sponsor: Gladwin, Mark, MD

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 6

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biotin-Labeled Red Blood Cells Infusion	Biotin-Labeled Red Blood Cells	Each participant will receive 2 transfusions of biotin labeled red blood cells.

Primary Outcome Measures

Name	Time	Method
Percentage of Biotin Labeled Red Blood Cells	24 hours, 30 days and 60 days after transfusion	This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Red Blood Cell Oxidative Hemolysis	5-7 days and 35-42 days following blood donation	This will be quantified by the evaluation of oxidative stress assays. We will define the associations between the primary endpoints and the quantification of oxidative hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of 2,2'-azobis-2-methyl-propanimidamide, dihydrochloride treated RBCs - supernatant cell-free hemoglobin of untreated red blood cells / total amount of hemoglobin) x 100.
The Percentage of Red Blood Cell Osmotic Hemolysis	5-7 days and 35-42 days following blood donation	This will be quantified by the evaluation of osmotic stress assays. We will define the associations between the primary endpoints and the quantification of osmotic hemolysis. The percent osmotic hemolysis is determined by this equation: (supernatant cell-free hemoglobin of pink test-treated RBCs / total amount of hemoglobin) x 100.
The Percentage of Storage Hemolysis	5-7 days and 35-42 days following blood donation	This will be quantified as percent hemolysis, which accounts for the levels of RBC-derived free hemoglobin in response to cold storage. We will define the associations between the primary endpoints and the quantification of storage hemolysis. Quantification of storage hemolysis is based on this equation: (sample hematocrit x levels of free hemoglobin obtained after centrifugation measured in the supernatant / the total amount of sample hemoglobin before centrifugation) x 100.