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Long Term Outcomes of Venous Thromboembolism (LOVE)

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ClinicalTrials.gov Identifier: NCT02268630
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

Tracking Information
First Submitted Date August 6, 2014
First Posted Date October 20, 2014
Last Update Posted Date February 16, 2017
Study Start Date January 2014
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 15, 2014)
Prevalence of post thrombotic syndrome and chronic thromboembolic pulmonary hypertension [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02268630 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 15, 2014)
  • Bleeding [ Time Frame: 9 years ]
    Rate of bleeding during treatment with anticoagulation
  • Recurrence rate [ Time Frame: 9 years ]
    Recurrence rate during treatment and after discontinuation of anticoagulation.
  • Mortality rate [ Time Frame: 9 years ]
    Mortality rate following deep vein thrombosis and /or pulmonary embolism.
  • Severity of pulmonary embolism [ Time Frame: 9 years ]
    Severity of PE based on CT (Fredrikstad score) and troponin level.
  • Incidence of cancer [ Time Frame: 9 years ]
    Incidence of cancer after diagnosis of venous tromboembolism in screened and unscreened patients
  • Compliance in the use of Elastic compression stockings [ Time Frame: 9 years ]
    Compliance in the use of Elastic compression stockings
  • Risk factors [ Time Frame: 9 years ]
    Risk factors for venous thromboembolism
  • Resource utilization [ Time Frame: 9 years ]
    Resource utilization (number of contacts with health care providers, INR tests during anticoagulation)
  • Post thrombotic syndrome according to CEAP [ Time Frame: 9 years ]
    PTS according to CEAP score
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Outcomes of Venous Thromboembolism
Official Title Long Term Outcomes of Venous Thromboembolism -the LOVE Study-
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with VTE in Østfold who fulfil study criteria will be invited to participate.
Condition
  • Post Thrombotic Syndrome
  • Chronic Thromboembolic Pulmonary Hypertension
  • Venous Thrombosis
Intervention Not Provided
Study Groups/Cohorts
  • Group A
    Patients treated with Warfarin for VTE
  • Grup B
    Patients treated with Rivaroxaban for VTE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 15, 2014)
460
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kristin K Utne, MD 004790417184 kristin.utne@gmail.com
Contact: Waleed Ghanima, PhD 004741303440 wghanima@gmail.com
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT02268630
Other Study ID Numbers LOVE1213
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ostfold Hospital Trust
Study Sponsor Ostfold Hospital Trust
Collaborators Not Provided
Investigators
Principal Investigator: Kristin K Utne, MD Ostfold Hospital Trust
Study Director: Waleed Ghanima, PhD Ostfold Hospital Trust
PRS Account Ostfold Hospital Trust
Verification Date February 2017