Detecting Autologous Transfusion by Measuring Alterations in the Dynamics of Red Blood Cell Maturation and Recycling
NCT ID: NCT02684747
Last Updated: 2018-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
40 participants
INTERVENTIONAL
2016-02-29
2018-05-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Treatment - Autologous Transfusion
Participants will be randomized to the treatment group (autologous transfusion)
Autologous Transfusion
Participants will receive autologous transfusion on Day 21
Control - Normal Saline (Placebo)
Participants will either be randomized to the control group (saline transfusion)
Control - Normal Saline (Placebo)
Participants will receive saline on Day 21
Interventions
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Autologous Transfusion
Participants will receive autologous transfusion on Day 21
Control - Normal Saline (Placebo)
Participants will receive saline on Day 21
Eligibility Criteria
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Inclusion Criteria
2. 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
3. The subjects should be well-trained endurance athletes. This group could consist of cyclists (road and mountain), triathletes, runners, long-distance swimmers, etc.
Exclusion Criteria
2. Any contraindication to blood donation as defined by the American Association of Blood Banks http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/QuestionsaboutBlood/UCM272981.pdf
3. Any chronic illness (e.g.diabetes, heart disease, hypotension, anemia, hemoglobinopathy, marrow diseases, leukemia/lymphoma, pregnancy, amenorrhea/female athlete triad)
4. Any abnormal CBC index or iron study; any blood dyscrasia
5. Abnormal blood and urine tests for doping agents (e.g. phthalates)
6. Positive uhCG or women who are attempting to get pregnant during the study period
7. Unwilling or unable to provide blood samples or receive a blood transfusion
8. Not a participant in endurance sports activities
9. Are currently on any medications that might affect hematologic parameters including, but not restricted to, hematopoietic medications
10. Subjects with a baseline hemoglobin above 16.7 g/dL, or baseline hematocrit below 35% or above 55%.
11. 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
18 Years
35 Years
ALL
Yes
Sponsors
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Sports Medicine Research and Testing Laboratory
INDUSTRY
Partnership for Clean Competition
OTHER
University of Utah
OTHER
Responsible Party
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Daniel Cushman
M.D.
Principal Investigators
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Daniel Cushman, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah Center for Clinical & Translational Science
Salt Lake City, Utah, United States
Countries
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References
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Cowell HR, Swickard JW. Autotransfusion in children's orthopaedics. J Bone Joint Surg Am. 1974 Jul;56(5):908-12. No abstract available.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Basson, M. Red blood cells by the numbers. Nature Medicine 16, 1 (2010).
Other Identifiers
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83533
Identifier Type: -
Identifier Source: org_study_id
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