D-Dimer and IPG for Recurrent Thrombosis (DIRECT)
Phase 3
Terminated
- Conditions
- Deep Vein ThrombosisPulmonary Embolism
- Registration Number
- NCT00182247
- Lead Sponsor
- Hamilton Health Sciences Corporation
- Brief Summary
To simplify and improve the diagnostic approach to patients with clinically suspected recurrent DVT by determining whether the results of the combination of IPG and d-dimer testing, using a whole blood agglutination assay, can be used in the management of such patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- suspected deep vein thrombosis
- history of previous DVT or PE
Exclusion Criteria
- comorbid condition limiting survival to less than 6 months
- contraindication to contrast medium (allergy, renal dysfunction, creatinine > 150mcmol/L)
- receiving long-term warfarin or heparin therapy
- received full-dose heparin therapy for more than 48 hours
- pregnancy
- symptomatic for pulmonary embolism
- absence of symptoms within 5 days of presentation
- geographic inaccessibility which precludes follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method symptomatic DVT and PE in follow-up
- Secondary Outcome Measures
Name Time Method death deep vein thrombosis diagnosed by venography in those randomized to that intervention
Trial Locations
- Locations (8)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
St. Joseph' Hospital
🇨🇦Hamilton, Ontario, Canada
Henderson General Hospital
🇨🇦Hamilton, Ontario, Canada
Chedoke Hospital
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
CHA - Pavillon Saint-Sacrement
🇨🇦Quebec, Canada
IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Hamilton General Hospital🇨🇦Hamilton, Ontario, Canada