Detecting Autologous Transfusion by Measuring Alterations in the Dynamics of Red Blood Cell Maturation and Recycling

NCT02684747 | Completed Early Phase 1 DMC

• 1 other identifier: 83533
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 40 subjects will be recruited for participation in this study. 20 subjects (10 males and 10 females) will be randomized to the active group (those receiving re-infusion of autologous blood) and 20 subjects (10 males and 10 females) will be randomized to the placebo group (receiving NS infusion).

Conditions

Blood Transfusion, Autologous; Blood Doping

Keywords

Healthy Volunteers; Sports Medicine; Athletes; Anti-doping

Outcome Measures

Primary Outcomes (4)

• Hematocrit

  This will be used within a mathematical model to define the volume (v) and hemoglobin (h) dynamics of a typical RBC as deterministic functions (f) and random fluctuations in the rates of these changes over time (ζ) (Patel, Patel, \& Higgins, 2015).

  8 weeks

• Hemoglobin

  This will be used within a mathematical model to define the volume (v) and hemoglobin (h) dynamics of a typical RBC as deterministic functions (f) and random fluctuations in the rates of these changes over time (ζ) (Patel, Patel, \& Higgins, 2015).

  8 weeks

• Reticulocyte count

  This will be used within a mathematical model to define the volume (v) and hemoglobin (h) dynamics of a typical RBC as deterministic functions (f) and random fluctuations in the rates of these changes over time (ζ) (Patel, Patel, \& Higgins, 2015).

  8 weeks

• Mean corpuscular volume

  This will be used within a mathematical model to define the volume (v) and hemoglobin (h) dynamics of a typical RBC as deterministic functions (f) and random fluctuations in the rates of these changes over time (ζ) (Patel, Patel, \& Higgins, 2015).

  8 weeks

Study Arms (2)

Treatment - Autologous Transfusion

EXPERIMENTAL

Participants will be randomized to the treatment group (autologous transfusion)

Other: Autologous Transfusion

Control - Normal Saline (Placebo)

PLACEBO COMPARATOR

Participants will either be randomized to the control group (saline transfusion)

Other: Control - Normal Saline (Placebo)

Interventions

Autologous Transfusion OTHER

Participants will receive autologous transfusion on Day 21

Treatment - Autologous Transfusion

Control - Normal Saline (Placebo) OTHER

Participants will receive saline on Day 21

Control - Normal Saline (Placebo)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18-35 years old
• Classified as low risk and will not have any major signs or symptoms suggestive of cardiovascular, pulmonary, or metabolic disease according to the American College of Sports Medicine's (ACSM) risk stratification categories
• The subjects should be well-trained endurance athletes. This group could consist of cyclists (road and mountain), triathletes, runners, long-distance swimmers, etc.

You may not qualify if:

• Age less than 18 or greater than 35 on the day of enrollment
• Any contraindication to blood donation as defined by the American Association of Blood Banks http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/UCM272981.pdf
• Any chronic illness (e.g.diabetes, heart disease, hypotension, anemia, hemoglobinopathy, marrow diseases, leukemia/lymphoma, pregnancy, amenorrhea/female athlete triad)
• Any abnormal CBC index or iron study; any blood dyscrasia
• Abnormal blood and urine tests for doping agents (e.g. phthalates)
• Positive uhCG or women who are attempting to get pregnant during the study period
• Unwilling or unable to provide blood samples or receive a blood transfusion
• Not a participant in endurance sports activities
• Are currently on any medications that might affect hematologic parameters including, but not restricted to, hematopoietic medications
• Subjects with a baseline hemoglobin above 16.7 g/dL, or baseline hematocrit below 35% or above 55%.
• Any subject that plans to participate in an organized athletic event (or USA Cycling sanctioned event) within 30 days following the re-infusion phase of the study will not be allowed to participate in the study

Sponsors & Collaborators

• University of Utah: lead
• Sports Medicine Research and Testing Laboratory: collaborator
• Partnership for Clean Competition: collaborator

Study Sites (1)

University of Utah Center for Clinical & Translational Science

Salt Lake City, Utah, 84132, United States

Location

Related Publications (11)

• Cowell HR, Swickard JW. Autotransfusion in children's orthopaedics. J Bone Joint Surg Am. 1974 Jul;56(5):908-12. No abstract available.

  PMID: 4847238 BACKGROUND

• Cregan P, Donegan E, Gotelli G. Hemolytic transfusion reaction following transfusion of frozen and washed autologous red cells. Transfusion. 1991 Feb;31(2):172-5. doi: 10.1046/j.1537-2995.1991.31291142950.x.

  PMID: 1996486 BACKGROUND

• Domen RE. Adverse reactions associated with autologous blood transfusion: evaluation and incidence at a large academic hospital. Transfusion. 1998 Mar;38(3):296-300. doi: 10.1046/j.1537-2995.1998.38398222875.x.

  PMID: 9563411 BACKGROUND

• Higgins JM, Mahadevan L. Physiological and pathological population dynamics of circulating human red blood cells. Proc Natl Acad Sci U S A. 2010 Nov 23;107(47):20587-92. doi: 10.1073/pnas.1012747107. Epub 2010 Nov 8.

  PMID: 21059904 BACKGROUND

• Kumar S, Goyal K, Dube SK, Dubey S, Bindra A, Kedia S. Anaphylactic reaction after autologous blood transfusion: A case report and review of the literature. Asian J Neurosurg. 2015 Apr-Jun;10(2):145-7. doi: 10.4103/1793-5482.154983.

  PMID: 25972952 BACKGROUND

• Morkeberg J, Belhage B, Ashenden M, Borno A, Sharpe K, Dziegiel MH, Damsgaard R. Screening for autologous blood transfusions. Int J Sports Med. 2009 Apr;30(4):285-92. doi: 10.1055/s-0028-1105938. Epub 2009 Feb 6.

  PMID: 19199200 BACKGROUND

• Popovsky MA, Whitaker B, Arnold NL. Severe outcomes of allogeneic and autologous blood donation: frequency and characterization. Transfusion. 1995 Sep;35(9):734-7. doi: 10.1046/j.1537-2995.1995.35996029156.x.

  PMID: 7570932 BACKGROUND

• Pottgiesser T, Sottas PE, Echteler T, Robinson N, Umhau M, Schumacher YO. Detection of autologous blood doping with adaptively evaluated biomarkers of doping: a longitudinal blinded study. Transfusion. 2011 Aug;51(8):1707-15. doi: 10.1111/j.1537-2995.2011.03076.x. Epub 2011 Mar 7.

  PMID: 21382045 BACKGROUND

• Solymos E, Guddat S, Geyer H, Flenker U, Thomas A, Segura J, Ventura R, Platen P, Schulte-Mattler M, Thevis M, Schanzer W. Rapid determination of urinary di(2-ethylhexyl) phthalate metabolites based on liquid chromatography/tandem mass spectrometry as a marker for blood transfusion in sports drug testing. Anal Bioanal Chem. 2011 Aug;401(2):517-28. doi: 10.1007/s00216-010-4589-4. Epub 2010 Dec 25.

  PMID: 21188579 BACKGROUND

• Weatherall DJ. Systems biology and red cells. N Engl J Med. 2011 Jan 27;364(4):376-7. doi: 10.1056/NEJMcibr1012683. No abstract available.

  PMID: 21268732 BACKGROUND

• Basson, M. Red blood cells by the numbers. Nature Medicine 16, 1 (2010).

  BACKGROUND

MeSH Terms

Interventions

Blood Transfusion, Autologous

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Daniel Cushman, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: February 18, 2016
• Study Start: February 1, 2016
• Primary Completion: May 5, 2018
• Study Completion: May 5, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)