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Blood Transfusion, AutologousEarly Phase 1NCT02684747

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

A Early Phase 1 study testing Autologous Transfusion in people with Blood Transfusion, Autologous and Blood Doping, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Blood Transfusion, Autologous, Blood Doping
What is being tested?
Autologous Transfusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Feb 2016to 5 May 2018
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah Center for Clinical & Translational Science

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

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).

Read the detailed description

Autologous blood transfusion is a major problem in a wide range of competitive sports. Methods with increased sensitivity, specificity, and feasibility are needed to identify athletes who cheat in this manner and compromise their health and the integrity of their sports in general. Complete blood counts (CBC) offer routine high-resolution assessment of the current hematologic status of individuals, providing estimates of a number of blood characteristics, such as the total hemoglobin concentration in the blood (HGB) and the volume fraction of cells in the blood (HCT). These CBC components are homeostatically controlled by the carefully regulated dynamic processes of red blood cell (RBC) production in and release from the bone marrow, RBC maturation in the peripheral circulation over the course of the ~100-day RBC lifespan, and clearance and recycling of senescent cells. Any significant perturbation to the circulating population of RBCs, like autologous transfusion, will immediately trigger compensatory modulation of one or more of these dynamic processes. The investigators believe quantification of these underlying dynamic processes will enable us to detect autologous transfusion. These dynamic RBC processes cannot currently be measured directly, but novel mathematical modeling enables their inference from routine complete blood and reticulocyte counts. The investigators propose to test the ability of modeled RBC dynamics to identify instances of autologous blood transfusion.

Being tested
Autologous Transfusion, Control - Normal Saline (Placebo)
Keywords
Healthy Volunteers, Sports Medicine, Athletes, Anti-doping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous TransfusionOther

    Participants will receive autologous transfusion on Day 21

  • Control - Normal Saline (Placebo)Other

    Participants will receive saline on Day 21

Study groups in NCT02684747
Study groupRoleWhat they receive
Treatment - Autologous TransfusionExperimentalParticipants will be randomized to the treatment group (autologous transfusion)
Receives: Other: Autologous Transfusion
Control - Normal Saline (Placebo)Placebo comparatorParticipants will either be randomized to the control group (saline transfusion)
Receives: Other: Control - Normal Saline (Placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 8 weeks

  2. 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).

    Measured: 8 weeks

  3. 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).

    Measured: 8 weeks

  4. 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).

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion5 May 2018
  4. Study completion5 May 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02684747
Sponsor's protocol ID
83533
Status last verified
May 2018
First submitted
27 Jan 2016
Last updated
14 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

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

    PubMed 4847238

  • 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.

    PubMed 1996486

  • 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.

    PubMed 9563411

  • 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.

    PubMed 21059904

  • 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.

    PubMed 25972952

  • 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.

    PubMed 19199200

  • 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.

    PubMed 7570932

  • 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.

    PubMed 21382045

  • 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.

    PubMed 21188579

  • 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.

    PubMed 21268732

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

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Autologous Transfusion in people with Blood Transfusion, Autologous and Blood Doping, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hematocrit (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02684747, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.

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