Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Blood Doping (Transfusion)
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|ClinicalTrials.gov Identifier: NCT03548766|
Recruitment Status : Not yet recruiting
First Posted : June 7, 2018
Last Update Posted : September 11, 2018
|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|
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 (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Homologous/Autologous Blood Doping- a Transfusion Study|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
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
- 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.
- 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.
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
|Contact: Sven C Vossemail@example.com|
|Contact: Abdulqadir Nashwanfirstname.lastname@example.org|
|Hamad Medical Corporation||Not yet recruiting|
|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|
|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|