Treatment of Polycythaemia Vera and Essential Thrombocythaemia: Influence on the Clot Structure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Fibrin polymerization; lag-time (in seconds)
研究概览
简要总结
Myeloproliferative neoplasms (MPN) such as Polycythemia Vera (PV) and, Essential Thrombocythaemia (ET) are rare clonal myeloid neoplasms associated with an increased risk of both venous and arterial thrombosis. Thrombotic complications are the main determinant of morbidity and in a less extend mortality.
Routine haemostasis analysis (TP, aPTT) are usually normal and are useless to demonstrate a hypercoagulable state. However, previous evidence suggests that global coagulation tests such as thrombin generation or thromboelastometry are able to detect signs of procoagulant imbalance in MPN. Similarly, current data seems to demonstrate that fibrin clot properties (clot permeability, turbidimetry, clot lysis time) properties is altered suggesting an hypercoagulable state.
Goals of PV and ET treatments are to control blood count to reduce the risk of thrombotic events. Moreover, new drugs such as Janus Kinase Inhibitors (JAKi) were recently licensed for PV and are under investigations on clinical trial for ET. It is currently unknown if treatments that were used for ET and PV, and especially JAKi are able to modify the hypercoagulable state that is observed in those diseases, and if there is difference between drugs.
To evaluate impact of MPN treatment on prothrombotic haemostatic profile, we propose to evaluate global coagulation and fibrin clot properties in MPN, depending on the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All men and women, older than 18 years, with a diagnosis of PV or ET (primary or secondary) according to the 2008 World Health Organization (WHO) classification.
排除标准
- •Lack of participant's consent;
- •Concomitant treatment with anticoagulant drugs (anti-vitamin K, heparin or direct oral anticoagulant drugs);
- •Active cancer other than non-melanoma skin cancer (defined as cancer diagnosis <5 years or treatment <2 years);
- •Recent infection (<30d);
- •Recent surgery (<30d);
- •Recent hospitalization (<30d);
- •Recent thromboembolic or cardiovascular event (<3m).
研究组 & 干预措施
PV
Patients with a diagnosis of polycythaemia vera.
干预措施: No cytoreductive vs cytoreductive drugs (Drug)
ET
Patients with a diagnosis of essential thrombocythaemia.
干预措施: No cytoreductive vs cytoreductive drugs (Drug)
结局指标
主要结局
Fibrin polymerization; lag-time (in seconds)
时间窗: At time of inclusion
Fibrin polymerization will be assessed by turbidity assay on plasma. Fibrin polymerization will be monitored at 340 nm after incubation with human thrombin and CaCl2. Results will report lag-time (seconds).
Fibrin polymerization; maximal absorbance
时间窗: At time of inclusion
Fibrin polymerization will be assessed by turbidity assay on plasma. Fibrin polymerization will be monitored at 340 nm after incubation with human thrombin and CaCl2. Results will report maximal absorbance.
Clot lysis time (in minutes)
时间窗: At time of inclusion
Fibrinolysis will be assessed by turbidity assay on plasma. Fibrinolysis will be monitored by adding tissue plasminogen activator (tPA). Results will report clot lysis time (minutes)
次要结局
- Quantitative parameters of thrombin generation test (TGT); endogenous thrombin potential (nM*minutes)(At time of inclusion)
- Clot permeation; permeation coefficient(At time of inclusion)
- Fibrin density by laser scanner confocal microscopy (number per 100 μm)(At time of inclusion)
- Quantitative parameters of thrombin generation test (TGT); peak (nM)(At time of inclusion)
- Quantitative parameters of thrombin generation test (TGT); time to peak (minutes)(At time of inclusion)
研究者
Dr Yan Beauverd
Physician
University Hospital, Geneva