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Completed

NCT Number: NCT02757898

Transfusion of Biotinylated Red Blood Cells

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

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.

In this study, blood is collected from healthy subjects, processed into packed red blood cell units, and either immediately afterwards or 40-42 days later the packed red blood cells are labeled with biotin. The biotin-labeled red blood cells are then re-infused back to the donor (autologous transfusion). Blood samples are then taken from the subject every week for up to 70 days (10 weeks) to track survival of the labeled red blood cells.

This study also seeks to demonstrate that biotin-labeled RBCs can be safely transfused back to autologous subjects without any adverse reactions. All participants will be followed to watch for the development of antibodies against biotin-labeled RBCs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • in good health

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

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

    Time frame: Up to 112 days

    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

Secondary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to 12 months

    The total number of participants who experience adverse events, including development of anti-biotin-RBC antibodies will be determined. In previous studies, antibodies for biotin-labeled RBCs have been seen in a small number of people for up to 12 months.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

RBC Survival Validation in Adult Humans Under Condition of Normal RBC Survival

Acronym: b-RBCs

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 2, 2016
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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