MDA D-Dimer / Recurrent DVT Study
Not Applicable
Completed
- Conditions
- Deep Vein Thrombosis
- Registration Number
- NCT00157599
- Lead Sponsor
- McMaster University
- Brief Summary
To determine whether treatment and further investigation can be safely withheld in patients who present with suspected recurrent deep vein thrombosis (DVT) and have either a (i) negative D-Dimer or (ii) a positive D-Dimer with normal serial compression ultrasound.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Age 18 or older
- Currently suspected for recurrent DVT
- Has a prior history of objectively documented DVT or PE
Exclusion Criteria
- Comorbid condition limiting survival to less than 3 months
- History of hypersensitivity to contrast medium
- Renal dysfunction with a creatinine of > 150 mcmol/L
- Treatment with full-dose therapeutic unfractionated or low molecular weight heparin that was initiated 24 hours or more prior to eligibility assessment
- Pregnancy or lactation
- Symptomatic for pulmonary embolism
- Absence of symptoms within five days prior to presentation
- Participation in another trial precluding the use of the diagnostic algorithm in this study
- Geographically inaccessible for follow-up
- Compression ultrasound, venogram, IPG, or D-dimer performed PRIOR to assessment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Suspected DVT during follow-up Suspected PE during follow-up
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
McMaster University Medical Centre
🇨🇦Hamilton, Ontario, Canada
Henderson Research Centre
🇨🇦Hamilton, Ontario, Canada
St. Joseph's Hospital
🇨🇦Hamilton, Ontario, Canada
Sir Mortimer B. Davis Jewish General
🇨🇦Montreal, Quebec, Canada
Academic Medical Centre
🇳🇱Amsterdam, Netherlands