Transfusion of Biotin-Labeled Red Blood Cells

NCT03364686 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY190203565R01HL098032-09
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

BioRBCs; Biotin labeled red blood cells

Outcome Measures

Primary Outcomes (1)

• Percentage of Biotin Labeled Red Blood Cells

  This will be determined using enumeration of biotinylated red blood cells obtained by flow cytometry from blood samples obtained at various time points from subjects with specified genetic mutations, compared with control subjects without the specified mutation. Percentage of Biotin Labeled Red Blood Cells is determined by Biotin Labeled Red Blood Cells in circulation at each time point/baseline Biotin Labeled Red Blood Cells in circulation x 100.

  24 hours, 30 days and 60 days after transfusion

Secondary Outcomes (3)

• 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

Study Arms (1)

Biotin-Labeled Red Blood Cells Infusion

EXPERIMENTAL

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

Biological: Biotin-Labeled Red Blood Cells

Interventions

Biotin-Labeled Red Blood Cells 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).

Biotin-Labeled Red Blood Cells Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gladwin, Mark, MD: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Limitations and Caveats

The clinical trial was terminated early due to challenges with enrollment and lack of study coordinator support. Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Darrell J. Triulzi, MD
• Organization: University of Pittsburgh

triudj@upmc.edu

412-209-7304

Study Officials

• Darrell Triulzi, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 6, 2017
• Study Start: September 16, 2019
• Primary Completion: March 2, 2021
• Study Completion: June 29, 2021
• Last Updated: April 21, 2022
• Results First Posted: April 21, 2022

Record last verified: 2022-03

Locations

US (1)