Trial | NCT03548766  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    12
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.
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 Started
Sep 20
2018
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Aug 11
2020

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

Biological Autologous Blood Transfusion

Autologous blood transfusion is the collection and re-infusion of the patient's own blood or blood components.

Healthy Subjects Experimental

Six healthy subjects will receive an ABT (Autologous Blood Transfusion)

Anemic Patients Experimental

Six patients with anemia will receive a HBT (Homologous Blood Transfusion)

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
No Results Posted