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临床试验/NCT03548766
NCT03548766Unknown3 期

Using DNA-Typing and Erythrocyte Microparticle Analysis to Detect Homologous/Autologous Blood Doping- a Transfusion Study

Hamad Medical Corporation1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年9月20日最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
12
试验地点
1
主要终点
Donor DNA (# of loci with triplets or quadruplets):

研究概览

简要总结

A total of 12 subjects will be recruited for participation in this study. 6 subjects will receive re-infusion of autologous blood, and 6 subjects (anemic patients) will receive a homologous transfusion.

详细描述

Homologous blood transfusions (HBT) and autologous blood transfusions (ABT) are abused by athletes to illegally increase their hemoglobin mass and subsequently improve oxygen transport.

Anti-Doping labs use flow-cytometry to detect HBT in cheating athletes, but athletes avoid being tested positive by matching their blood for minor blood groups before transfusion. Recent publications suggest that DNA typing by Capillary Electrophoresis or RT-PCR might be an alternative way to detect this kind of doping in athletes. Unfortunately, no data exist on the clearance of DNA after transfusion of one bag of blood using this methodology.

For the detection of doping with ABT, there is no direct method available and only the biological passport, a longitudinal collection of hematological parameters can indicate doping. Recently RBC Microparticles (RBC-MPs) have been described as a potential biomarker for autologous transfusion. However, also for this methodology, no data on the clearance time of RBC-MPs are available.

Thus, in this World Anti-Doping Agency (WADA) approved and sponsored project. The investigators plan to perform a clinical trial in which six healthy subjects receive an ABT and six healthy subjects or patients a HBT. Blood samples will be collected before and at several time-points after transfusion. For the detection of HBT the samples will be analyzed by the official method (cytometry), and the two genotyping methods (STR and RT-PCR) to compare these different techniques and to see if DNA-typing can replace cytometry.

For the ABT the collected samples will be analyzed for RBC-MPs on a cytometer dedicated for Microparticles.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •both genders,
  • •age 20-50 years and
  • •preferably physically active but no elite athletes subjected to Anti-Doping testing.

排除标准

  • •vulnerable subjects
  • •not willing to participate
  • •not signing the ICF
  • •patients with end-organ failure

研究组 & 干预措施

Healthy Subjects

Experimental

Six healthy subjects will receive an ABT (Autologous Blood Transfusion)

干预措施: Autologous Blood Transfusion (Biological)

Anemic Patients

Experimental

Six patients with anemia will receive a HBT (Homologous Blood Transfusion)

干预措施: Homologous Blood Transfusion (Biological)

结局指标

主要结局

Donor DNA (# of loci with triplets or quadruplets):

时间窗: 12 months

Clearance Kinetics of donor DNA which is transferred during the transfusion of one bag of homologous blood will be established.

Cellular Microparticles (10^3/uL):

时间窗: 12 months

Clearance Kinetics of cellular microparticles which are introduced during an autologous blood transfusion and are originating from red blood cells during blood storage will be established.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Dr. Mohamed A Yassin ,MD

Hematology Consultant

Hamad Medical Corporation

研究点 (1)

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