Clinical trial NCT03364686: Transfusion of Biotin-Labeled Red Blood Cells
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Healthy Volunteers
Keywords: BioRBCs
Biotin labeled red blood cells
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-12-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Biotin Labeled Red Blood Cells
timeFrame: 24 hours, 30 days and 60 days after transfusion
Secondary outcomes:
measure: The Percentage of Storage Hemolysis
timeFrame: 5-7 days and 35-42 days following blood donation
measure: The Percentage of Red Blood Cell Osmotic Hemolysis
timeFrame: 5-7 days and 35-42 days following blood donation
measure: The Percentage of Red Blood Cell Oxidative Hemolysis
timeFrame: 5-7 days and 35-42 days following blood donation
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Darrell Triulzi, MD
role: PRINCIPAL_INVESTIGATOR
References: