Status:
TERMINATED
Transfusion of Biotin-Labeled Red Blood Cells
Lead Sponsor:
Gladwin, Mark, MD
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 stor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03364686
Start Date
September 16 2019
End Date
June 29 2021
Last Update
April 21 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213