Long Term Outcomes of Venous Thromboembolism (LOVE)

Long Term Outcomes of Venous Thromboembolism -the LOVE Study-

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 460

Contacts and Locations

• Study Contact: Name: Kristin K Utne, MD; Phone Number: 004790417184; Email: kristin.utne@gmail.com
• Study Contact Backup: Name: Waleed Ghanima, PhD; Phone Number: 004741303440; Email: wghanima@gmail.com

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Not yet recruiting
    • Ullevål University Hospital
  • Akershus
    • Lørenskog, Akershus, Norway, 1478
      • Recruiting
      • Akershus University Hospital
  • Ostfold
    • Fredrikstad, Ostfold, Norway, 1606
      • Recruiting
      • Ostfold Hospital Trust
      • Principal Investigator: Kristin K Utne, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with VTE in Østfold who fulfil study criteria will be invited to participate.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; Patients treated with Warfarin for VTE
Grup B; Patients treated with Rivaroxaban for VTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ostfold Hospital Trust
• Investigators: Principal Investigator: Kristin K Utne, MD, Ostfold Hospital Trust; Study Director: Waleed Ghanima, PhD, Ostfold Hospital Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Rivaroxaban; Anticoagulation; Chronic thromboembolic pulmonary hypertension; Post-thrombotic syndrome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Peripheral Vascular Diseases; Venous Insufficiency; Phlebitis; Hypertension; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Hypertension, Pulmonary; Postthrombotic Syndrome; Postphlebitic Syndrome
• Other Study ID Numbers: LOVE1213