Long Term Outcomes of Venous Thromboembolism -the LOVE Study-
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 460
- 试验地点
- 3
- 主要终点
- Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
研究概览
简要总结
This prospective observational follow-up study is designed to assess the long-term outcomes after Venous thromboembolism (VTE) and to assess the effect of the new oral anticoagulant (NOAC) rivaroxaban on the prevalence of post-thrombotic syndrome (PTS).
The study will not be testing any formal hypothesis.
详细描述
This prospective observational follow-up study is designed to assess the long-term outcomes after VTE and to assess the effect of NOAC (rivaroxaban) on the prevalence of PTS. All patients diagnosed and treated for VTE at SØF from 01.01.2011 will be invited to participate in this study. Newly diagnosed patients will be recruited and followed-up according to the study schedule which is based on state of the art international guidelines.
First follow-up will be performed at the end of treatment period, which is usually 3 or 6 months after an event of VTE, or at one year if patients will be put on permanent AC. Thereafter, patients will be followed-up annually for at least 5 years or up to the end of the study, i.e for 10 years.
The primary endpoints of the study are the development of PTS and CTEPH after VTE. There will be 3 visits: at 3 or 6 months depending on the duration of AC, at 2 and 5 years, in addition to a visit for TTE at 6 months. Remaining follow-ups will be performed by phone or by mail. All patients with PE will be examined by TTE 6 months after the diagnosis of PE. Those with signs of PAH will be referred for further work-up to establish the presence or absence of CTEPH at specialized centres. Patients with DVT will be evaluated for PTS at 2 and 5 years and for CTEPH if they develop dyspnoea. As for part b of the primary objective, the study will allow inclusion of patients with previous DVT diagnosed after 01.01.11.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Patients with objectively verified first time DVT diagnosed after 01.01.11 for study A, OR objectively verified DVT and/or PE dignosed after 01.04.14 for study B.
- •18 years of age
- •Signed informed written consent
排除标准
- •Patients who refuse to consent
- •Patients who have been treated with other anticoagulants than thoose included in the study
- •Patients who can not participate due to logistic reasons
结局指标
主要结局
Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension
时间窗: 5 years
Determine the prevalence of post thrombotic syndrome as defined by Villalta score at 2- and 5 years in an unselected population of venous thromboembolism patients. Prevalence of chronic thromboembolic pulmonary hypertension in at 2- and 5 years in an unselected population of pulmonary embolism patients.
次要结局
- Bleeding(9 years)
- Recurrence rate(9 years)
- Mortality rate(9 years)
- Severity of pulmonary embolism(9 years)
- Incidence of cancer(9 years)
- Compliance in the use of Elastic compression stockings(9 years)
- Risk factors(9 years)
- Resource utilization(9 years)
- Post thrombotic syndrome according to CEAP(9 years)