Transfusion of Biotin-Labeled Red Blood Cells

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: Biotin-Labeled Red Blood Cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biotin-Labeled Red Blood Cells Infusion<br>Each participant will receive 2 transfusions of biotin labeled red blood cells. | Biological: Biotin-Labeled Red Blood Cells<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Biotin Labeled Red Blood Cells | 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. | 24 hours, 30 days and 60 days after transfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Storage Hemolysis | 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. | 5-7 days and 35-42 days following blood donation | 
| The Percentage of Red Blood Cell Osmotic Hemolysis | 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. | 5-7 days and 35-42 days following blood donation | 
| The Percentage of Red Blood Cell Oxidative Hemolysis | 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. | 5-7 days and 35-42 days following blood donation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BioRBCs, Biotin labeled red blood cells