Long Term Outcomes of Venous Thromboembolism (LOVE)

Ostfold Hospital Trust

Status

Unknown

Conditions

Post Thrombotic Syndrome

Chronic Thromboembolic Pulmonary Hypertension

Venous Thrombosis

Study type

Observational

Funder types

Other

Identifiers

NCT02268630

LOVE1213

Details and patient eligibility

About

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.

Full description

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.

Enrollment

460 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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