Biological Parameters Changes After Autologous Blood Transfusion of Red Blood Cells (200 ml) in Healthy Volunteers. (AUTOT-SPORT)

April 20, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Île-de-France Region
      • Chesnay, Île-de-France Region, France, 78150
        • EFS de Versailles, centre de soins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Controls not transfused
no transfusion
Other: No transfusion
no transfusion
Experimental: Autotransfusion: blood stored at 4 ° C
Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at 4 ° C for 33 days
Procedure: Autologous Blood Transfusion
Autotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 33 days
Experimental: Autotransfusion: blood stored at -80°C
Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at -80°C for 33 days
Procedure: Autologous Blood Transfusion
Autotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 33 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
erythrocytes (/µL)
Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
hemoglobin (g/dL)
Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
Hematocrit (%)
Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
Mean corpuscular volume (fL)
Baseline (Day 1), until 2 days after autotransfusion
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)
Baseline (Day 1), until 2 days after autotransfusion
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
Baseline (Day 1), until 2 days after autotransfusion
Change in microparticles detected in plasma
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
fluorescence-activated cell sorting
Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
Reticulocyte by Sysmex analyzer
Baseline (Day 1), until 2 days after autotransfusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in phthalate in urine
Time Frame: Baseline (Day 1), until 2 days after autotransfusion
Assay by LC-MS/MS in urine
Baseline (Day 1), until 2 days after autotransfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut National de la Santé Et de la Recherche Médicale, France
Etablissement Français du Sang
URC-CIC Paris Descartes Necker Cochin
World Anti-Doping Agency
GR-Ex executive comitee
Laboratoire antidopage français (LADF)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olivier HERMINE, MD, PhD, Assistance Publique-Hôpitaux Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K180405J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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