Status:
UNKNOWN
Two Weeks of Low Molecular Weight Heparin for Distal Vein Thrombosis
Lead Sponsor:
Monash Medical Centre
Collaborating Sponsors:
Southern Health, Victoria
Eastern Health, Victoria
Conditions:
Venous Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether a limited duration of treatment (two weeks of low molecular weight treatment) is a safe and effective treatment for distal deep vein thrombosis of the...
Detailed Description
Approximately 50% of symptomatic episodes of deep vein thrombosis (DVT) will be confined to the calf veins (distal DVT). The proportion of distal DVT that propagate to the proximal veins, increasing t...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older with acute symptomatic provoked or unprovoked distal vein thrombosis (axial or muscular veins but not involving trifurcation or distal popliteal vein)
- Absence of symptomatic pulmonary embolism
Exclusion
- DVT involving trifurcation or more proximal leg veins on imaging
- Prior DVT
- Active malignancy ie present at time of diagnosis, or on treatment, or treatment completed within 3 months
- Ongoing risk factors for propagation e.g. immobility (\>50% of day in bed or ≥72 hours), plaster cast or non-weight bearing
- Other indication for therapeutic anticoagulation (e.g. AF)
- Active gastro-oesophageal ulceration or bleeding
- Other high risk for bleeding (e.g. recent neurosurgery, vascular retinopathy, coagulopathy)
- Platelet count \<80 x 109/L
- Renal impairment (CrCl \<30ml/min) • Pregnancy or lactation
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2014
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT01252420
Start Date
November 1 2010
End Date
November 1 2014
Last Update
December 6 2010
Active Locations (4)
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1
Prince of Wales Hospital
Sydney, New South Wales, Australia, 2031
2
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
3
Monash Medical Centre, Southern Health
Melbourne, Victoria, Australia, 3168
4
Christchurch Hospital
Christchurch, Canterbury, New Zealand, 8011