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临床试验/NCT03778502
NCT03778502已完成不适用

International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism

University of Malta24 个研究点 分布在 10 个国家目标入组 358 人开始时间: 2019年10月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
358
试验地点
24
主要终点
Rationale for the use of the direct oral anticoagulants

研究概览

简要总结

Unusual site venous thromboembolism (VTE) refers to thrombosis occurring in venous districts outside the veins of the lower extremities and the pulmonary arteries, and includes splanchnic vein thrombosis (SVT), cerebral vein thrombosis (CVT), retinal vein thrombosis, ovarian vein thrombosis, and renal vein thrombosis. The use of the novel direct oral anticoagulants (DOAC), thrombin or factor Xa-inhibitors (such as dabigatran, apixaban, edoxaban, rivaroxaban), in patients with unusual VTE in clinical practice is increasing. Through an international multicentre prospective registry, the investigators aim to evaluate the rationale for the use of the DOAC for the treatment of unusual site VTE and to assess the safety and effectiveness of this approach in real life clinical practice.

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

入选标准

  • Objective diagnosis of venous thrombosis not involving the upper limbs, lower limbs and pulmonary arteries
  • Treatment with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban)

排除标准

  • Enrolment in interventional studies evaluating the DOAC for the treatment of unusual site VTE

结局指标

主要结局

Rationale for the use of the direct oral anticoagulants

时间窗: Baseline

Possible reasons for choosing one of the direct oral anticoagulant (multiple choice question)

次要结局

  • Rate of vascular events(12 months)
  • Rate of major bleeding events(12 months)

研究者

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

Nicoletta Riva

Lecturer

University of Malta

研究点 (24)

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