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Transfusion of Biotin-Labeled Red Blood Cells

This study is not yet open for participant recruitment.
Verified November 2017 by Michael Risbano, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT03364686
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Michael Risbano, University of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Biological: Biotin-Labeled Red Blood Cells Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage Outcomes

Resource links provided by NLM:


Further study details as provided by Michael Risbano, University of Pittsburgh:

Primary Outcome Measures:
  • Length of time biotin-labeled RBCs can be detected following infusion [ Time Frame: up to 165 days ]
    This will be determined using enumeration of biotinylated RBCs obtained by flow cytometry from blood samples obtained at various time points from subjects.


Secondary Outcome Measures:
  • The percentage of storage hemolysis [ Time Frame: 5-7 days and 35-42 days following blood donation ]
    This will be quantified as percent hemolysis, which accounts for the levels of RBC-derived free hemoglobin in response to cold storage. We will define the associations between the primary endpoints and the quantification of storage hemolysis.

  • The percentage of red blood cell osmotic hemolysis [ Time Frame: 5-7 days and 35-42 days following blood donation ]
    This will be quantified by the evaluation of osmotic stress assays. We will define the associations between the primary endpoints and the quantification of osmotic hemolysis.

  • The percentage of red blood cell oxidative hemolysis [ Time Frame: 5-7 days and 35-42 days following blood donation ]
    This will be quantified by the evaluation of oxidative stress assays. We will define the associations between the primary endpoints and the quantification of oxidative hemolysis.


Estimated Enrollment: 125
Anticipated Study Start Date: April 1, 2018
Estimated Study Completion Date: June 30, 2023
Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental - Biotin-Labeled Red Blood Cells Infusion
Each participant will receive 2 transfusions of biotin labeled red blood cells.
Biological: 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65 years old
  • Weight ≥110 lbs
  • Hemoglobin ≥ 12.5 g/dL or hematocrit ≥ 38% for women and ≥ 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, BP >140/95mmHg
  • Systolic blood pressure <100 mmHg and/or diastolic blood pressure < 60 mmHg on the study day.
  • Positive Direct Antiglobulin Test (DAT)
  • 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 (> 30ml)
  • 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 oral hypoglycemics or 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364686


Contacts
Contact: Nicole Helbling, RN, BSN, MS 412-692-2285 nlr8@pitt.edu

Sponsors and Collaborators
Gladwin, Mark, MD
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Michael Risbano, MD University of Pittsburgh
  More Information

Responsible Party: Michael Risbano, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03364686     History of Changes
Other Study ID Numbers: PRO16110442
5R01HL098032-09 ( U.S. NIH Grant/Contract )
First Submitted: November 22, 2017
First Posted: December 6, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael Risbano, University of Pittsburgh:
BioRBCs
Biotin labeled red blood cells

Additional relevant MeSH terms:
Biotin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs