Transfusion of Biotin-Labeled Red Blood Cells

NCT ID: NCT03364686

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2021-06-29

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Biotin-Labeled Red Blood Cells Infusion

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

Group Type: EXPERIMENTAL

Biotin-Labeled Red Blood Cells

Intervention Type: BIOLOGICAL

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).

Interventions

Biotin-Labeled Red Blood Cells

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).

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Gladwin, Mark, MD

INDIV

Sponsor Role: lead

Responsible Party

Darrell Triulzi MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darrell Triulzi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01HL098032-09

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY19020356

Identifier Type: -

Identifier Source: org_study_id