Transfusion of Biotin-Labeled Red Blood Cells for the Evaluation of Genetic Factors That Contribute to Donor Differences in Red Blood Cell Storage Outcomes

Transfusion of Biotin-Labeled Red Blood Cells



Sponsors


Source

University of Pittsburgh

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-04-01

Completion Date

2023-06-30

Primary Completion Date

2022-12-31

Phase

Phase 2

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Length of time biotin-labeled RBCs can be detected following infusion
up to 165 days

Secondary Outcome

Measure

Time Frame

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

Enrollment

125

Condition


Intervention

Intervention Type

Biological

Intervention Name


Description

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).

Arm Group Label

Experimental - Biotin-Labeled Red Blood Cells Infusion


Eligibility

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

Gender

All

Minimum Age

18 Years

Maximum Age

65 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Michael Risbano, MD
Principal Investigator
University of Pittsburgh

Overall Contact

Last Name

Nicole Helbling, RN, BSN, MS

Phone

412-692-2285

Email



Verification Date

2017-11-01

Lastchanged Date

2017-11-30

Firstreceived Date

2017-11-22

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

University of Pittsburgh

Investigator Full Name

Michael Risbano

Investigator Title

Assistant Professor of Medicine


Keywords


Has Expanded Access

No

Secondary Id

5R01HL098032-09

Number Of Arms

1

Intervention Browse

Mesh Term

Biotin


Arm Group

Arm Group Label

Experimental - Biotin-Labeled Red Blood Cells Infusion

Arm Group Type

Experimental

Description

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


Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Basic Science

Masking

None (Open Label)


Study First Submitted

November 22, 2017

Study First Submitted Qc

November 30, 2017

Study First Posted

December 6, 2017

Last Update Submitted

November 30, 2017

Last Update Submitted Qc

November 30, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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