Transfusion of Biotin-Labeled Red Blood Cells

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

Sponsors

Lead Sponsor: Gladwin, Mark, MD

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Source University of Pittsburgh
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.

Overall Status Recruiting
Start Date 2019-09-16
Completion Date 2024-12-01
Primary Completion Date 2023-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Length of time biotin-labeled RBCs can be detected following infusion up to 165 days
Secondary Outcome
Measure Time Frame
The percentage of storage hemolysis 5-7 days and 35-42 days following blood donation
The percentage of red blood cell osmotic hemolysis 5-7 days and 35-42 days following blood donation
The percentage of red blood cell oxidative hemolysis 5-7 days and 35-42 days following blood donation
Number of Membrane microvesicle formation 5-7 days and 35-42 days following blood donation
Percentage of biotin labeled red blood cells 2-4 hours after transfusion
Enrollment 175
Condition
Intervention

Intervention Type: Biological

Intervention Name: Biotin-Labeled Red Blood Cells

Description: 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).

Arm Group Label: Biotin-Labeled Red Blood Cells Infusion

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Darrell Triulzi, MD Principal Investigator University of Pittsburgh
Overall Contact

Last Name: Carolyn Newkirk, MEd, RD

Phone: 4126922437

Email: [email protected]

Location
Facility: Status: Contact: University of pittsburgh Carolyn Newkirk, MEd, RD 412-692-2437 [email protected]
Location Countries

United States

Verification Date

2021-03-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Pittsburgh

Investigator Full Name: Darrell Triulzi MD

Investigator Title: Professor

Keywords
Has Expanded Access No
Number Of Arms 1
Arm Group

Label: Biotin-Labeled Red Blood Cells Infusion

Type: Experimental

Description: Each participant will receive 2 transfusions of biotin labeled red blood cells.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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