Long Term Outcomes of Venous Thromboembolism

• Conditions: Post Thrombotic Syndrome; Venous Thrombosis; Chronic Thromboembolic Pulmonary Hypertension

• Registration Number: NCT02268630
• Lead Sponsor: Ostfold Hospital Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-10-15
• Study First Posted: 2014-10-20
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension	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.

Secondary Outcome Measures

Name	Time	Method
Severity of pulmonary embolism	9 years	Severity of PE based on CT (Fredrikstad score) and troponin level.
Mortality rate	9 years	Mortality rate following deep vein thrombosis and /or pulmonary embolism.
Recurrence rate	9 years	Recurrence rate during treatment and after discontinuation of anticoagulation.
Bleeding	9 years	Rate of bleeding during treatment with anticoagulation
Incidence of cancer	9 years	Incidence of cancer after diagnosis of venous tromboembolism in screened and unscreened patients
Compliance in the use of Elastic compression stockings	9 years	Compliance in the use of Elastic compression stockings
Risk factors	9 years	Risk factors for venous thromboembolism
Resource utilization	9 years	Resource utilization (number of contacts with health care providers, INR tests during anticoagulation)
Post thrombotic syndrome according to CEAP	9 years	PTS according to CEAP score

Trial Locations

Locations (3)

Ostfold Hospital Trust; 🇳🇴 Fredrikstad, Ostfold, Norway

Ullevål University Hospital; 🇳🇴 Oslo, Norway

Akershus University Hospital; 🇳🇴 Lørenskog, Akershus, Norway