Transfusion of Biotin-Labeled Red Blood Cells
- 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
- 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
- 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.
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States