Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Blood Doping (Transfusion)

August 9, 2020 updated by: Dr. Mohamed A Yassin ,MD, Hamad Medical Corporation

Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Homologous/Autologous Blood Doping- a Transfusion Study

A total of 12 subjects will be recruited for participation in this study. 6 subjects will receive re-infusion of autologous blood, and 6 subjects (anemic patients) will receive a homologous transfusion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Homologous blood transfusions (HBT) and autologous blood transfusions (ABT) are abused by athletes to illegally increase their hemoglobin mass and subsequently improve oxygen transport.

Anti-Doping labs use flow-cytometry to detect HBT in cheating athletes, but athletes avoid being tested positive by matching their blood for minor blood groups before transfusion. Recent publications suggest that DNA typing by Capillary Electrophoresis or RT-PCR might be an alternative way to detect this kind of doping in athletes. Unfortunately, no data exist on the clearance of DNA after transfusion of one bag of blood using this methodology.

For the detection of doping with ABT, there is no direct method available and only the biological passport, a longitudinal collection of hematological parameters can indicate doping. Recently RBC Microparticles (RBC-MPs) have been described as a potential biomarker for autologous transfusion. However, also for this methodology, no data on the clearance time of RBC-MPs are available.

Thus, in this World Anti-Doping Agency (WADA) approved and sponsored project. The investigators plan to perform a clinical trial in which six healthy subjects receive an ABT and six healthy subjects or patients a HBT. Blood samples will be collected before and at several time-points after transfusion. For the detection of HBT the samples will be analyzed by the official method (cytometry), and the two genotyping methods (STR and RT-PCR) to compare these different techniques and to see if DNA-typing can replace cytometry.

For the ABT the collected samples will be analyzed for RBC-MPs on a cytometer dedicated for Microparticles.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Qatar
      • Doha, Qatar
        • Recruiting
        • Hamad Medical Corporation
        • Contact:
          • Mohamed Yassin
        • Principal Investigator:
          • Sven Voss
        • Principal Investigator:
          • Mohamed Yassin
        • Sub-Investigator:
          • Zeyd Merenkov
        • Sub-Investigator:
          • Saloua Hmissi
        • Sub-Investigator:
          • Aysha Al-Malki
        • Sub-Investigator:
          • Mohammad Abdulla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • both genders,
  • age 20-50 years and
  • preferably physically active but no elite athletes subjected to Anti-Doping testing.

Exclusion Criteria:

  • vulnerable subjects
  • not willing to participate
  • not signing the ICF
  • patients with end-organ failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy Subjects
Six healthy subjects will receive an ABT (Autologous Blood Transfusion)
Biological: Autologous Blood Transfusion
Autologous blood transfusion is the collection and re-infusion of the patient's own blood or blood components.
EXPERIMENTAL: Anemic Patients
Six patients with anemia will receive a HBT (Homologous Blood Transfusion)
Biological: Homologous Blood Transfusion
Homologous, or allogenic, blood transfusions involves someone collecting and infusing the blood of a compatible donor into him/herself.
Other Names:
  • Allogenic Blood Transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Donor DNA (# of loci with triplets or quadruplets):
Time Frame: 12 months
Clearance Kinetics of donor DNA which is transferred during the transfusion of one bag of homologous blood will be established.
12 months
Cellular Microparticles (10^3/uL):
Time Frame: 12 months
Clearance Kinetics of cellular microparticles which are introduced during an autologous blood transfusion and are originating from red blood cells during blood storage will be established.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamad Medical Corporation

Collaborators

Sidra Medical and Research Center
World Anti-Doping Agency
Anti-Doping Lab Qatar
Laboratorio Antidoping FMSI

Investigators

  • Study Chair: Sven Voss, ADLQ
  • Principal Investigator: Francesco Donati, Laboratorio Antidoping FMSI, Rome, Italy
  • Principal Investigator: Costas Georgakopoulos, ADLQ
  • Principal Investigator: Mohammed Alsayrafi, ADLQ
  • Principal Investigator: Jean-Charles Grivel, Sidra Medicine
  • Principal Investigator: Christophe Raynaud, Sidra Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 20, 2018

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

May 6, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (ACTUAL)

June 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 9, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRC-02-18-070

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Disease

Clinical Trials on Autologous Blood Transfusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe