Blood Disease, Blood Doping, Blood Transfusion, Autologous, Blood Transfusion, Homologous
Conditions
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.
Interventions
BIOLOGICALHomologous Blood Transfusion
Homologous, or allogenic, blood transfusions involves someone collecting and infusing the blood of a compatible donor into him/herself.
BIOLOGICALAutologous Blood Transfusion
Autologous blood transfusion is the collection and re-infusion of the patient's own blood or blood components.
Sponsors
World Anti-Doping Agency
Anti-Doping Lab Qatar
Sidra Medicine
Laboratorio Antidoping FMSI
Hamad Medical Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Qatar
Contacts
Primary ContactSven C Voss
Backup ContactAbdulqadir Nashwan
Outcome results
None listed