Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism
- Conditions
- Idiopathic Venous Thromboembolism
- Interventions
- Other: Application of the"Men continue and HER DOO2" rule
- Registration Number
- NCT00967304
- Lead Sponsor
- Ottawa Hospital Research Institute
- Brief 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.
- Detailed Description
Up to 50% of patients with a first episode of venous thromboembolism (VTE) have no identifiable cause (i.e. are unprovoked VTEs). The risk of recurrent VTE in this large group of patients with unprovoked VTE after 3-6 months of anticoagulant therapy is 5-10.8% in the year following discontinuation of oral anticoagulant therapy. One in six to one in twenty recurrences of a new VTE are fatal. Given the intermediate risks of recurrence in unselected unprovoked VTE patients, clinicians do not have clear guidance on whether to continue or discontinue anticoagulants in patients with unprovoked VTE. Recently attention has turned to the concept of risk stratification to identify subgroups of patients with unprovoked VTE who could safely discontinue oral anticoagulation therapy (OAT).
In the REVERSE I study, a clinical decision rule derivation study conducted from 2001 to 2006, we developed and internally validated the clinical decision rule "Men continue and HER DOO2" that identifies patients with a first unprovoked VTE who likely have a low risk of recurrent VTE and could safely discontinue OAT subsequent to 5-7 months of OAT. The present study will evaluate if the "Men continue and HER DOO2" rule (comprised of gender, elevated D-dimer levels, post-thrombotic signs, obesity, and older age) is safe, clinically useful, and reproducible when prospectively implemented in multiple centers and a variety of settings. If this clinical decision rule is validated, it will provide physicians with important information to allow them to more confidently identify unprovoked VTE patients at low risk of VTE recurrence who may not need to continue OAT.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2779
- First episode of major unprovoked VTE
- VTE objectively proven
- VTE treated for 5-12 months with anticoagulant therapy authorized for the REVERSE II study (initial or ongoing therapy)
- Absence of recurrent VTE during the treatment period
- Less than 18 years of age
- Patients who have already discontinued anticoagulant therapy
- Patients requiring ongoing anticoagulation for reasons other than VTE
- Being treated for a recurrent unprovoked VTE
- Patients with high risk thrombophilia
- patients who plan on using exogenous estrogen(OCP,HRT)if anticoagulant therapy is discontinued
- Patients with pregnancy associated VTE
- Geographically inaccessible for follow-up
- Patients unable or unwilling to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Discontinue OAT or AAA Application of the"Men continue and HER DOO2" rule Patients classified as being at low risk of recurrent VTE by the "HER DOO2"rule. If the clinical decision rule indicates that a patient is at low recurrence risk (\<3% per year); anticoagulant therapy will be withdrawn and the participant will then be followed for 1 year for any VTE recurrence and/or bleeding.
- Primary Outcome Measures
Name Time Method The primary study outcome is the incidence of adjudicated recurrent major VTE at 1 year in patients deemed by the "Men and HER DOO2" CDR to be at low risk of recurrent VTE. One year
- Secondary Outcome Measures
Name Time Method Any VTE 1 year event rate in low risk patients One year Clinical utility of the rule One year Major bleeding 1 year event rate in un-anticoagulated low risk patients One year Major VTE 1 year event rate in high risk patients who continue anticoagulant therapy One year Major VTE 1 year event rate in high risk patients who discontinue anticoagulant therapy One year Major Bleeding 1 year event rate in high risk patients One year Inter-observer reliability of the clinical decision rule One year
Trial Locations
- Locations (23)
Penobscot Bay Medical Center
🇺🇸Rockport, Maine, United States
UC Davis
🇺🇸Santa Monica, California, United States
Prince of Wales Hospital
🇦🇺Sydney, New South Wales, Australia
Ottawa Health Research Institute
🇨🇦Ottawa, Ontario, Canada
Hamilton Health Sciences Corporation
🇨🇦Hamilton, Ontario, Canada
SMBD Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
St. Mary's Hospital - CHUM
🇨🇦Montreal, Quebec, Canada
Hopital Enfant Jesus
🇨🇦Quebec, Canada
Centre Hospitalier Regional Universitaire de Brest
🇫🇷Brest, France
Sahyadri Speciality Hospital
🇮🇳Pune, India
Orange Lifesciences
🇮🇳Nirmaya, India
Jashvant Patel Clinic
🇮🇳Surat, India
Hopitaux Universitaires de Geneve
🇨ðŸ‡Geneva, Switzerland
University Health Network
🇨🇦Toronto, Ontario, Canada
Victoria Hospital
🇨🇦London, Ontario, Canada
CDHA-Queen Elizabeth II Health Science Centre
🇨🇦Halifax, Nova Scotia, Canada
Hamilton Health Sciences Center
🇨🇦Hamilton, Ontario, Canada
Hopital Sacre Coeur
🇨🇦Montreal, Quebec, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada
Saskatchewan Drug Research Institute
🇨🇦Saskatoon, Saskatchewan, Canada
CUB Hopital Erasme
🇧🇪Brussels, Belgium
Shefali Centre
🇮🇳Shefali, India
Duke University
🇺🇸Durham, North Carolina, United States