NCT04962984尚未招募不适用
Evaluation of Hypercoagulability by Thrombin Generation Test in Beta-thalassemia Major
Central Hospital, Nancy, France0 个研究点目标入组 45 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 主要终点
- Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls
研究概览
简要总结
This study aims to evaluate the persistence of a hypercoagulable state in chronically-transfused patients with beta thalassemia major, by using the thrombin generation test (performed in whole blood and plasma). Patients will be compared with 2 control groups: 1/ healthy volunteers and 2/ carriers of beta-thalassemia trait
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with de Beta-thalassemia major
- •Patient with regular blood transfusion regimen (every 4 - 6 weeks)
- •informed and signed consent
- •weight > 30kg
- •Hemoglobin > 7g/dL
排除标准
- •Emergency situation
- •Patients receiving antithrombotic drugs (anticoagulants such as Vitamin K antagonism, heparin or direct oral anticoagulant) or antiplatelet drugs;
- •women of childbearing age without contraception
- •pregnancy
- •deprivation of liberty
- •no consent
结局指标
主要结局
Evaluation of hypercoagulability using endogenous thrombin potential (ETP) between patients and controls
时间窗: 6 months
Measurement of the area under the thrombin generation curve (ie ETP) in THAL+ patients, before and after transfusion, as compared with ETP measured in controls groups (THAL- and healthy volunteers)
次要结局
- Evaluation of endogenous thrombin potential's variations before and after transfusion in THAL+ patients over 3 transfusion episodes(6 months)
研究者
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