Biological Parameters Changes After Autologous Blood Transfusion of Red Blood Cells (200 ml) in H… (NCT03889834) | Clinical Trial Compass
CompletedNot Applicable
Biological Parameters Changes After Autologous Blood Transfusion of Red Blood Cells (200 ml) in Healthy Volunteers.
France28 participantsStarted 2024-01-25
Plain-language summary
The purpose of this study is to evaluate if differences between samples of subjects obtained before autologous blood transfusion or samples of non-transfused subjects and samples of subjects after autologous blood transfusion can be identified. Analyses performed will focus on the morphological and biochemical parameters of red blood cells and associated microparticles. The final goal would be to find markers of autologous blood transfusion, that could be used to identify such doping practice.
Who can participate
Age range18 Years – 35 Years
SexMALE
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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
What they're measuring
1
Change in hematological parameters
Timeframe: Baseline (Day 1), until 2 days after autotransfusion
2
Change in hematological parameters
Timeframe: Baseline (Day 1), until 2 days after autotransfusion
3
Change in hematological parameters
Timeframe: Baseline (Day 1), until 2 days after autotransfusion
4
Change in hematological parameters
Timeframe: Baseline (Day 1), until 2 days after autotransfusion
5
Change in hematological parameters
Timeframe: Baseline (Day 1), until 2 days after autotransfusion
6
Variation in Red blood cells morphology
Timeframe: Baseline (Day 1), until 2 days after autotransfusion
7
Change in expression of cell surface proteins in red blood cells transfusion
Timeframe: Baseline (Day 1), until 2 days after autotransfusion