Transfusion of Biotin-Labeled Red Blood Cells (NCT03364686) | Clinical Trial Compass
TerminatedPhase 2
Transfusion of Biotin-Labeled Red Blood Cells
Stopped: Due to enrollment challenges related to COVID and lack of coordinator support
United States6 participantsStarted 2019-09-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 di…
What they're measuring
1
Percentage of Biotin Labeled Red Blood Cells
Timeframe: 24 hours, 30 days and 60 days after transfusion