MDA D-Dimer / Recurrent DVT Study
Status
Completed
Conditions
Deep Vein Thrombosis
Treatments
Procedure: various diagnostic measures for DVT (e.g., CUS)
Details and patient eligibility
About
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.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Diagnostic
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
Trial contacts and locations
6
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Data sourced from clinicaltrials.gov
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