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

Phase 3

• Conditions: Blood Transfusion, Homologous; Blood Disease; Blood Transfusion, Autologous; Blood Doping
• Interventions: Biological: Homologous Blood Transfusion; Biological: Autologous Blood Transfusion

• Registration Number: NCT03548766
• Lead Sponsor: Hamad Medical Corporation

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.

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 Timeline

• Study First Submitted: 2018-05-06
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-06-07
• Study Start: 2018-09-20
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-09
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anemic Patients	Homologous Blood Transfusion	Six patients with anemia will receive a HBT (Homologous Blood Transfusion)
Healthy Subjects	Autologous Blood Transfusion	Six healthy subjects will receive an ABT (Autologous Blood Transfusion)

Primary Outcome Measures

Name	Time	Method
Donor DNA (# of loci with triplets or quadruplets):	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):	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.

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar