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

NCT03889834 | Completed

• 1 other identifier: K180405J
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

The Focus is on the Detection of the Consequences of Autologous Blood Transfusion in Healthy Volunteers

Keywords

autologous transfusion; doping; blood markers; detection

Outcome Measures

Primary Outcomes (8)

• 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

• Change in hematological parameters

  Reticulocyte by Sysmex analyzer

  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

Secondary Outcomes (1)

• Change in phthalate in urine

  Baseline (Day 1), until 2 days after autotransfusion

Study Arms (3)

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

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

Procedure: Autologous Blood Transfusion

Controls not transfused

OTHER

no transfusion

Other: No transfusion

Interventions

Autologous Blood Transfusion PROCEDURE

Autotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 33 days

Autotransfusion: blood stored at -80°C; Autotransfusion: blood stored at 4 ° C

No transfusion OTHER

no transfusion

Controls not transfused

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• World Anti-Doping Agency: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Laboratoire antidopage français (LADF): collaborator
• GR-Ex executive comitee: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Etablissement Français du Sang: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

EFS de Versailles, centre de soins

Chesnay, Île-de-France Region, 78150, France

Location

MeSH Terms

Interventions

Blood Transfusion, Autologous

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Olivier HERMINE, MD, PhD

  Assistance Publique-Hôpitaux Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: March 26, 2019
• Study Start: January 25, 2024
• Primary Completion: March 27, 2025
• Study Completion: April 2, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)