Evaluating the effects of autologous blood transfusion in healthy volunteers
Modification of Biological Parameters After Autologous Blood Transfusion of a Small Volume of Packed Red Blood Cells (200 Ml) in Healthy Volunteers
This study is testing how different types of autologous blood transfusions affect healthy volunteers to see if there are any changes that could help spot doping in sports.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Male |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Le Chesnay-Rocquencourt) |
| Trial ID | NCT03889834 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the biological changes that occur after autologous blood transfusion in healthy volunteers. It involves a randomized, double-blinded design where participants are divided into three groups: those receiving refrigerated blood, those receiving frozen blood, and a control group with no transfusion. Blood samples will be collected at various points to analyze morphological and biochemical parameters of red blood cells and associated microparticles. The ultimate goal is to identify potential markers of autologous blood transfusion that could indicate doping practices in sports.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male volunteers aged 18 to 35 who regularly engage in sports activities.
Not a fit: Patients with medical conditions that contraindicate blood drawing or sports practice will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of reliable markers for detecting autologous blood transfusion, enhancing anti-doping efforts in sports.
How similar studies have performed: While the approach of identifying blood markers for doping is established, this specific methodology of assessing autologous transfusion effects in healthy volunteers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male between 18 and 35 years old * Without health problem nor disease requiring regular medical treatment * Free from any intercurrent acute pathology over 7 days * Healthy volunteers who have regularly sport activity, able to have blood sample and is out-of-competition during the research * Subject who did not practice a competition (or exhaustive training ) 3 days before the blood sample and the autotransfusion * Affiliated to a social security regimen Exclusion Criteria: * Subject with contraindication for drawing blood * Subject with medical pathology contraindicating sport practice * Subject under treatments or drugs in the list of products prohibited for sports practice and competitions, in particular erythropoeitins and erythropoiesis-stimulating agents (updated list of World Anti-Doping Agency https://www.wada-ama.org/fr/liste-des-restrictions). * Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion * Subject without a social security regimen * Subject under guardianship or curatorship * Subject participating in any Interventional study * Positive HIV and/or hepatitis serology * Discovery of a hematological disease
Where this trial is running
Le Chesnay-Rocquencourt
- EFS de Versailles, centre de soins — Le Chesnay-Rocquencourt, France (Recruiting)
Study contacts
- Principal investigator: Olivier HERMINE, MD, PhD — Assistance Publique-Hôpitaux Paris
- Study coordinator: Olivier Hermine, MD, PhD
- Email: olivier.hermine@aphp.fr
- Phone: +33 (0)1 44 49 51 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.