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

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: Completed
• Conditions: The Focus is on the Detection of the Consequences of Autologous Blood Transfusion in Healthy Volunteers
• Intervention / Treatment: Other: No transfusion; Procedure: Autologous Blood Transfusion

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: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in hematological parameters	erythrocytes (/µL)	Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters	hemoglobin (g/dL)	Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters	Hematocrit (%)	Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters	Mean corpuscular volume (fL)	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)	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	Baseline (Day 1), until 2 days after autotransfusion
Change in microparticles detected in plasma	fluorescence-activated cell sorting	Baseline (Day 1), until 2 days after autotransfusion
Change in hematological parameters	Reticulocyte by Sysmex analyzer	Baseline (Day 1), until 2 days after autotransfusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in phthalate in urine	Assay by LC-MS/MS in urine	Baseline (Day 1), until 2 days after autotransfusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: 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: Principal Investigator: Olivier HERMINE, MD, PhD, Assistance Publique-Hôpitaux Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): April 2, 2026

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: detection; autologous transfusion; doping; blood markers
• Additional Relevant MeSH Terms: Therapeutics; Biological Therapy; Blood Transfusion; Blood Transfusion, Autologous
• Other Study ID 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