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

Hamad Medical Corporation (HMC)

Status and phase: Unknown; Phase 3

Conditions: Blood Transfusion, Autologous; Blood Disease; Blood Transfusion, Homologous; Blood Doping

Treatments: Biological: Autologous Blood Transfusion; Biological: Homologous Blood Transfusion

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03548766

MRC-02-18-070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Healthy Subjects

Experimental group

Description:

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

Treatment:

Biological: Autologous Blood Transfusion

Anemic Patients

Experimental group

Description:

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

Treatment:

Biological: Homologous Blood Transfusion