Long Term Outcomes of Venous Thromboembolism

Venous Thrombosis Clinical Trial

— LOVE  

Official title:

Long Term Outcomes of Venous Thromboembolism -the LOVE Study-

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02268630
• Other study ID #: LOVE1213
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2014
• Last updated: February 15, 2017
• Start date: January 2014
• Est. completion date: October 2023

Study information

• Verified date: February 2017
• Source: Ostfold Hospital Trust
• Contact: Kristin K Utne, MD
• Phone: 004790417184
• Email: kristin.utne[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Post Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Locations

Country	Name	City	State
Norway	Ostfold Hospital Trust	Fredrikstad	Ostfold
Norway	Akershus University Hospital	Lørenskog	Akershus
Norway	Ullevål University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ostfold Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension	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.	5 years
Secondary	Bleeding	Rate of bleeding during treatment with anticoagulation	9 years
Secondary	Recurrence rate	Recurrence rate during treatment and after discontinuation of anticoagulation.	9 years
Secondary	Mortality rate	Mortality rate following deep vein thrombosis and /or pulmonary embolism.	9 years
Secondary	Severity of pulmonary embolism	Severity of PE based on CT (Fredrikstad score) and troponin level.	9 years
Secondary	Incidence of cancer	Incidence of cancer after diagnosis of venous tromboembolism in screened and unscreened patients	9 years
Secondary	Compliance in the use of Elastic compression stockings	Compliance in the use of Elastic compression stockings	9 years
Secondary	Risk factors	Risk factors for venous thromboembolism	9 years
Secondary	Resource utilization	Resource utilization (number of contacts with health care providers, INR tests during anticoagulation)	9 years
Secondary	Post thrombotic syndrome according to CEAP	PTS according to CEAP score	9 years