Modification of Biological Parameters After Autologous Blood Transfusion of a Small Volume of Packed Red Blood Cells (200 ml) in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in expression of cell surface proteins in red blood cells transfusion
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Autotransfusion: blood stored at 4 ° C
Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at 4 ° C for 33 days
干预措施: Autologous Blood Transfusion (Procedure)
Controls not transfused
no transfusion
干预措施: No transfusion (Other)
Autotransfusion: blood stored at -80°C
Intervention: Autologous Blood Transfusion of packed red blood cells (200 ml) stored at -80°C for 33 days
干预措施: Autologous Blood Transfusion (Procedure)
结局指标
主要结局
Change in expression of cell surface proteins in red blood cells transfusion
时间窗: 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
时间窗: Baseline (Day 1), until 2 days after autotransfusion
fluorescence-activated cell sorting
Variation in Red blood cells morphology
时间窗: Baseline (Day 1), until 2 days after autotransfusion
By amnis imaging flow cytometryProteins in Red blood cells (Wblot/ELISA/FACS)
Change in hematological parameters
时间窗: Baseline (Day 1), until 2 days after autotransfusion
erythrocytes (/µL)
次要结局
- Change in phthalate in urine(Baseline (Day 1), until 2 days after autotransfusion)