Long Term Outcomes of Venous Thromboembolism

  • STATUS
    Recruiting
  • End date
    Oct 21, 2023
  • participants needed
    460
  • sponsor
    Ostfold Hospital Trust
Updated on 21 January 2021
anticoagulants
rivaroxaban
noac
venous thromboembolism
thromboembolism
blood clot
dvts

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.

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 SF 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.

Details
Condition Venous Thrombosis, Deep Vein Thrombosis, Venous Thrombosis, Venous stasis, Thromboembolism, Thromboembolism, Thrombosis, Thrombosis, Blood Clots, Blood Clots, Chronic Thromboembolic Pulmonary Hypertension, CTEPH, Deep Vein Thrombosis, thromboembolic pulmonary hypertension, post thrombotic syndrome
Clinical Study IdentifierNCT02268630
SponsorOstfold Hospital Trust
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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