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临床试验/NCT04470986
NCT04470986尚未招募不适用

International Registry on the Diagnosis and Treatment of Inferior Vena Cava Thrombosis

Sheba Medical Center0 个研究点目标入组 200 人开始时间: 2021年6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
入组人数
200
主要终点
Rates of venous thromboembolism (VTE) recurrence

研究概览

简要总结

This study will focus on patients having inferior vena cava (IVC) thrombosis, either with or without thrombosis in other veins.

The purpose of this study is to assess risk factors, safety and effectiveness of treatment options, and outcomes of patients with IVC thrombosis.

详细描述

Thrombosis of the inferior vena cava (IVC) is a rare form of deep venous thrombosis (DVT). Optimal treatment strategies and clinical outcomes are not well established.

This multicenter, international, observational study will assess the effectiveness and safety of current treatment options in patients with IVC thrombosis, and describe the long-term outcomes of patients with IVC thrombosis.

Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT will be included. Information will be collected on baseline characteristics, risk factors for thrombosis, symptoms, mode of diagnosis, presence of concomitant lower limb DVT, PE, IVC filter or unusual site thrombosis (splanchnic, gonadal and renal veins), treatment modalities (anticoagulation and/or thrombolysis), choice of anticoagulant, dose and duration of treatment, recanalization assessment (if available), recurrence of VTE during follow up, bleeding according to International Society on Thrombosis and Haemostasis criteria, development post-thrombotic syndrome (PTS) according to Villalta score and mortality during follow up. Patients should be followed up for 24 months from diagnosis. The number of visits is left to the discretion of the treating physician, but information on clinical outcomes at two intermediate time points is requested.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Rates of venous thromboembolism (VTE) recurrence

时间窗: 2 Years

Recurrence of any venous thrombosis (not previously diagnosed)

Rates of major bleeding

时间窗: 2 Years

Major bleeding per International Society on Thrombosis and Haemostasis criteria Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692- 4.

Rate of all cause mortality

时间窗: 2 Years

Mortality (patient's death) from any cause

次要结局

  • Rates of thrombosis recanalization(2 Years)
  • Rates of clinically relevant non-major bleeding(2 Years)
  • Rates of post-thrombotic syndrome (PTS)(2 Years)

研究者

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

Dr. Omri Cohen

Unusual site thrombosis service

Sheba Medical Center

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