Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03548766
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : August 11, 2020
Sponsor:
Collaborators:
World Anti-doping Agency
Anti-Doping Lab Qatar
Sidra Medical and Research Center
Laboratorio Antidoping FMSI
Information provided by (Responsible Party):
Dr. Mohamed A Yassin ,MD, Hamad Medical Corporation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Disease Blood Transfusion, Autologous Blood Doping Blood Transfusion, Homologous Biological: Homologous Blood Transfusion Biological: Autologous Blood Transfusion Phase 3

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Homologous/Autologous Blood Doping- a Transfusion Study
Actual Study Start Date : September 20, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Allogenic Blood Transfusion


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548766


Contacts
Layout table for location contacts
Contact: Sven C Voss 0097455481955 svoss@adlqatar.qa
Contact: Abdulqadir Nashwan 0097466473549 anashwan@hamad.qa

Locations
Layout table for location information
Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar
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         
Sponsors and Collaborators
Hamad Medical Corporation
World Anti-doping Agency
Anti-Doping Lab Qatar
Sidra Medical and Research Center
Laboratorio Antidoping FMSI
Investigators
Layout table for investigator information
Study Chair: Sven Voss ADLQ
Principal Investigator: Mohamed Yassin Hamad Medical Corporation
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Dr. Mohamed A Yassin ,MD, Hematology Consultant, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03548766    
Other Study ID Numbers: MRC-02-18-070
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Hematologic Diseases