Transfusion of Biotinylated Red Blood Cells

NCT02757898 | Completed Phase 1 Results

• 3 other identifiers: IRB00085954R01HL095479-06P01HL086773-06A1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study how red blood cells (RBCs) survive in a person's circulation, and how that survival may be different in red blood cells that are donated and stored prior to being transfused. Investigators will study this by collecting blood samples from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will then be re-infused back into the participant and blood samples will be taken weekly for 10 weeks to assess the number of labeled cells in the samples.

Conditions

Anemia

Keywords

Red Blood Cell (RBC) transfusion; Biotin labeled red blood cells

Outcome Measures

Primary Outcomes (2)

• Number of Participants That Had bRBC Detectable at 70 Days Post-intervention

  The length of time biotin-labeled RBCs can be detected following re-infusion. The number of participants was determined at day 70 by taking blood samples from each of them

  70 days post-intervention

• Length of Time Differentially Labeled Biotin-labeled RBCs Can be Distinguished From One Another

  The length of time that the three different concentrations of biotin labeling on the RBCs can be distinguished from one another will be determined by taking blood samples from each participant for 70 days

  Up to 112 days

Secondary Outcomes (1)

• Number of Participants Experiencing Adverse Events

  Up to 12 months

Study Arms (1)

Biotin-Labeled Red Blood Cell (RBC) Infusion

EXPERIMENTAL

Blood will be drawn from participants and labeled with biotin before being re-infused back to the participant. Blood samples will be obtained weekly over 10 weeks.

Drug: Biotin-Labeled Red Blood Cells (RBCs)

Interventions

Biotin-Labeled Red Blood Cells (RBCs) DRUG

500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit. For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection. For participants 3 through 8, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant. Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs.

Biotin-Labeled Red Blood Cell (RBC) Infusion

Eligibility Criteria

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

You may qualify if:

• in good health

You may not qualify if:

• anemia (defined as hemoglobin \< 8 g/dL)
• chronic disease, including diabetes, heart or lung disease, poorly managed hypertension, and peripheral vascular disease
• ongoing consumption of biotin or raw egg supplements
• history of a bleeding disorder
• evidence of anemia at initial screening
• women who are pregnant or plan to become pregnant

Sponsors & Collaborators

• Emory University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr. John Roback
• Organization: Emory University

jroback@emory.edu

404-712-1774

Study Officials

• John D Roback, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: January 11, 2017
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: May 9, 2023
• Results First Posted: May 9, 2023

Record last verified: 2023-05

Locations

US (1)