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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Blood Transfusion, Autologous, Blood Doping

In brief

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).

Key facts

Study ID

NCT02684747

Run by

University of Utah

People needed

40

Starts

2016-02-01

Expected to finish

2018-05-05

Last updated by the study team

2018-05-14

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University of Utah Center for Clinical & Translational Science — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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