The Focus is on the Detection of the Consequences of Autologous Blood Transfusion in Healthy VolunteersAUTOT-SPORTNCT03889834
Biological Parameters Changes After Autologous Blood Transfusion of Red Blood Cells (200 ml) in Healthy Volunteers.
A study testing Autologous Blood Transfusion and No transfusion in people with The Focus is on the Detection of the Consequences of Autologous Blood Transfusion in Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- The Focus is on the Detection of the Consequences of Autologous Blood Transfusion in Healthy Volunteers
- What is being tested?
- Autologous Blood Transfusion and No transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2024to 2 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Subject participating in any Interventional study
- Positive HIV and/or hepatitis serology
- Discovery of a hematological disease
Trial locations and contacts
1 site in 1 country.
France1 site
EFS de Versailles, centre de soins
Chesnay, Île-de-France Region, 78150
About this study
Official title: Modification of Biological Parameters After Autologous Blood Transfusion of a Small Volume of Packed Red Blood Cells (200 ml) in Healthy Volunteers
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.
Read the detailed description
Methodology and study design:
Pr Olivier Hermine, coordinator of the laboratory of Excellence GR-EX regrouping EFS (Etablissement Français du Sang) and INSERM (Institut National de la Santé et de la Recherche Médicale) partners, and leader of the Centre d'Investigation Clinique (CIC) Necker (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 33 days later.
A clinical randomized double-blinded two-phase study will be conducted. Volunteers will be separated in 3 groups:
- Group 1: Volunteers with regular sports activities without Autologous Blood Transfusion (ABT)T (n=10)
- Group 2: Volunteers with regular sports activities receiving a 200ml ABT with refrigerated blood (n=10)
- 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 (Versailles, France). ABT as well as collection of samples will be performed at the CIC Necker (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 (LADF) for haematological analysis (Orsay, 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.
- Being tested
- Autologous Blood Transfusion, No transfusion
- Keywords
- autologous transfusion, doping, blood markers, detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Blood TransfusionProcedure or surgery
Autotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 33 days
No transfusionOther
no transfusion
| Study group | Role | What they receive |
|---|---|---|
| Autotransfusion: blood stored at 4 ° C | Experimental | Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at 4 ° C for 33 days Receives: Procedure: Autologous Blood Transfusion |
| Autotransfusion: blood stored at -80°C | Experimental | Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at -80°C for 33 days Receives: Procedure: Autologous Blood Transfusion |
| Controls not transfused | Other | no transfusion Receives: Other: No transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hematological parameters
erythrocytes (/µL)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
hemoglobin (g/dL)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Hematocrit (%)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Mean corpuscular volume (fL)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Reticulocyte by Sysmex analyzer
Measured: Baseline (Day 1), until 2 days after autotransfusion
Variation in Red blood cells morphology
By amnis imaging flow cytometryProteins in Red blood cells (Wblot/ELISA/FACS)
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in expression of cell surface proteins in red blood cells transfusion
Western blot /ELISA/ fluorescence-activated cell sorting of red blood cells
Measured: Baseline (Day 1), until 2 days after autotransfusion
Change in microparticles detected in plasma
fluorescence-activated cell sorting
Measured: Baseline (Day 1), until 2 days after autotransfusion
Secondary outcomes (1)
Change in phthalate in urine
Assay by LC-MS/MS in urine
Measured: Baseline (Day 1), until 2 days after autotransfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start25 Jan 2024
- Primary completion27 Mar 2025
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus is on the Detection of the Consequences of Autologous Blood Transfusion in Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire antidopage français (LADF), World Anti-Doping Agency, GR-Ex executive comitee, Institut National de la Santé Et de la Recherche Médicale, France, Etablissement Français du Sang, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier HERMINE, MD, PhD, Principal investigator, Assistance Publique-Hôpitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889834
- Sponsor's protocol ID
- K180405J
- Acronym
- AUTOT-SPORT
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2019
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Biological Parameters After Autologous Blood Transfusion of a Small Volume of Packed Red Blood Cells (200 ml) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03889834
- Acronym / sponsor ID
- AUTOT-SPORT / K180405J
- Keywords
- autologous transfusion, doping, blood markers, detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Laboratoire antidopage français (LADF), World Anti-Doping Agency, GR-Ex executive comitee, Institut National de la Santé Et de la Recherche Médicale, France, Etablissement Français du Sang, URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 27 Mar 2025 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methodology and study design:
Pr Olivier Hermine, coordinator of the laboratory of Excellence GR-EX regrouping EFS (Etablissement Français du Sang) and INSERM (Institut National de la Santé et de la Recherche Médicale) partners, and leader of the Centre d'Investigation Clinique (CIC) Necker (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 33 days later.
A clinical randomized double-blinded two-phase study will be conducted. Volunteers will be separated in 3 groups:
- Group 1: Volunteers with regular sports activities without Autologous Blood Transfusion (ABT)T (n=10)
- Group 2: Volunteers with regular sports activities receiving a 200ml ABT with refrigerated blood (n=10)
- 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 (Versailles, France). ABT as well as collection of samples will be performed at the CIC Necker (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 (LADF) for haematological analysis (Orsay, 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autotransfusion: blood stored at 4 ° C | Experimental | Procedure: Autologous Blood TransfusionIntervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at 4 ° C for 33 days |
| Autotransfusion: blood stored at -80°C | Experimental | Procedure: Autologous Blood TransfusionIntervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at -80°C for 33 days |
| Controls not transfused | Other | Other: No transfusionno transfusion |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Blood TransfusionAutotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 33 days | Procedure or surgery | Autotransfusion: blood stored at -80°C, Autotransfusion: blood stored at 4 ° C |
| No transfusionno transfusion | Other | Controls not transfused |
Primary outcome
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
erythrocytes (/µL)
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
hemoglobin (g/dL)
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
Hematocrit (%)
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
Mean corpuscular volume (fL)
Change in hematological parameters
Time frame: Baseline (Day 1), until 2 days after autotransfusion
Reticulocyte by Sysmex analyzer
Variation in Red blood cells morphology
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 1), until 2 days after autotransfusion
fluorescence-activated cell sorting
1 secondary outcome
Change in phthalate in urine
Time frame: Baseline (Day 1), until 2 days after autotransfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier HERMINE, MD, PhD principal investigator
Assistance Publique-Hôpitaux Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Blood Transfusion and No transfusion in people with The Focus is on the Detection of the Consequences of Autologous Blood Transfusion in Healthy Volunteers, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hematological parameters (time frame: Baseline (Day 1), until 2 days after autotransfusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.