MedTrace Logo

Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism

NCT00967304 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2779

Last updated 2016-09-01

No results posted yet for this study

Summary

The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.

Conditions

  • Idiopathic Venous Thromboembolism

Interventions

OTHER

Application of the"Men continue and HER DOO2" rule

Consecutive patients will have the"Men continue and HER DOO2" rule applied by the attending physician between 5 - 12 months after treatment for a first unprovoked objectively proven major VTE. "Men continue and HER DOO2" rule: all men continue oral anticoagulants and women with 2 or more of the following features after 5-7 months of OAT should continue oral anticoagulants:1) HER - any Hyperpigmentation, Edema and Redness of either lower extremity, 2) Vidas D-dimer ≥250ug/L, 3) Obesity - BMI ≥30 kg/m2 and 4) Older age - Age ≥65 years.

Sponsors & Collaborators

  • BioMérieux

    collaborator INDUSTRY

  • Centre Hospitalier Régional et Universitaire de Brest

    collaborator OTHER

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Marc Rodger, MD, MSc · Ottawa Hospital Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2015-01-31
Completion
2016-07-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • India
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00967304 on ClinicalTrials.gov