AUTOT-SPORT: Biological Parameters Changes After Autologous Blood Transfusion of Red Blood Cells (200 ml) in Healthy Volunteers.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Methodology and study design:
Pr Olivier Hermine, coordinator of the laboratory of Excellence GR-EX regrouping EFS (Etablissement Français du Sang) and INTS (Institut National de Transfusion Sanguine) partners, and leader of the Centre d'Investigation Clinique (CIC) IMAGINE (Hospital Necker, Paris, France) will assure the promotion of the clinical study for Paris Hospital consortium AP-HP (assistance Publique-Hôpitaux de Paris).
To reproduce two potential scenarios of autologous transfusion by an athlete, 1 bag of blood packed red blood cells (after leuko deprivation and centrifugation) will be either stored at 4°C or frozen at -80°C after addition of 40% w/v glycerol. Reinfusion will be performed 31 days later.
A clinical randomized double-blinded two-phase study will be conducted. Volunteers will be separated in 3 groups:
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Group 1: Volunteers with regular sports activities without Autologous Blood Transfusion (ABT)T (n=10)
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Group 2: Volunteers with regular sports activities receiving a 200ml ABT with refrigerated blood (n=10)
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Group 3: Volunteers with regular sports activities receiving a 200ml ABT with frozen blood (n=10)
To ensure volunteers safety, collection, preparation and pretransfusion blood testing will be performed by EFS at hospital Pitié-Salpêtrière (Paris, France). ABT as well as collection of samples will be performed at the IMAGINE Institute (Paris, France). Blood samples will be collected before blood removal, the day of the ABT just before reinfusion and after 3 hours, 8 hours, 24 hours and 48 hours post-ABT. To perform all the experiments 25ml blood (4x 5 ml
BD Vacutainer EDTA tubes) will be taken at each time point:
1 will be dispatched to the French anti-doping laboratory for haematological analysis (Châtenay-Malabry, France), 2 to the EFS (Créteil, France) for RBC and MPs morphological characterization and quantification (using antigen markers, band 3 on the surface of MPs), 2 to INTS for MPs isolation, characterization (band 3 on the surface of MPs and RBC) and for proteomic analysis and Western-Blot.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Autotransfusion: blood stored at 4 ° C Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at 4 ° C for 31 days |
Procedure: Autologous Blood Transfusion
Autotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 31 days
|
| Experimental: Autotransfusion: blood stored at -80°C Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at -80°C for 31 days |
Procedure: Autologous Blood Transfusion
Autotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 31 days
|
| Other: Controls not transfused no transfusion |
Other: No transfusion
no transfusion
|
Outcome Measures
Primary Outcome Measures
- Change in hematological parameters [Baseline (Day 1), until 2 days after autotransfusion]
erythrocytes (/µL)
- Change in hematological parameters [Baseline (Day 1), until 2 days after autotransfusion]
hemoglobin (g/dL)
- Change in hematological parameters [Baseline (Day 1), until 2 days after autotransfusion]
Hematocrit (%)
- Change in hematological parameters [Baseline (Day 1), until 2 days after autotransfusion]
Mean corpuscular volume (fL)
- Change in hematological parameters [Baseline (Day 1), until 2 days after autotransfusion]
Reticulocyte by Sysmex XT2000i analyzer
- Variation in Red blood cells morphology [Baseline (Day 1), until 2 days after autotransfusion]
By amnis imaging flow cytometryProteins in Red blood cells (Wblot/ELISA/FACS)
- Change in expression of cell surface proteins in red blood cells transfusion [Baseline (Day 1), until 2 days after autotransfusion]
Western blot /ELISA/ fluorescence-activated cell sorting of red blood cells
- Change in microparticles detected in plasma [Baseline (Day 1), until 2 days after autotransfusion]
fluorescence-activated cell sorting
Secondary Outcome Measures
- Change in phthalate in urine [Baseline (Day 1), until 2 days after autotransfusion]
Assay by LC-MS/MS in urine
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male between 18 and 35 years old
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Without health problem nor disease requiring regular medical treatment
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free from any intercurrent acute pathology over 7 days
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healthy volunteers who have regularly sport activity, able to have blood sample and is out-of-competition during the research
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Subject who did not practiced a competition (or exhaustive training ) 3 days before the blood sample and the autotransfusion
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Affiliated to a social security regimen
Exclusion Criteria:
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- subject with contraindication for drawing blood
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Subject with medical pathology contraindicating sport practice - Subject under treatments or drugs in the Prohibited List updated each year by the World Anti-Doping Agency.
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Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion
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Subject without to a social security regimen
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Subject under guardianship or curatorship
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Subject participating in any Interventional study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Etablissement Français du Sang IDF, Hôpital de la Pitié Salpêtrière | Paris | IDF | France | 75013 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- French Anti-Doping Agency (AFLD)
- World Anti-doping Agency
- GR-Ex executive comitee
- Institut National de la Transfusion Sanguine
- Etablissement Français du Sang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- K180405J