Status:
COMPLETED
DUTCH CAVA-trial: CAtheter Versus Anticoagulation Alone for Acute Primary (Ilio)Femoral DVT.
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Acute Thrombosis of Deep Veins of Proximal Lower Extremity
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Rationale: Iliofemoral deep venous thrombosis (IFDVT) is associated with significant post thrombotic morbidity. The presence of both obstruction and reflux significantly increases the chances for deve...
Eligibility Criteria
Inclusion
- Objectively documented IFDVT
- Acute stage IFDVT, complaints less than 14 days
- Life expectancy longer than 6 months
- First thrombus in the affected limb
Exclusion
- History of GI bleeding within 1 year
- History of cardiovascular accident /central nervous system disease within 1 year
- Severe hypertension (\>180/100 mmHg)
- Active malignancy
- Major surgery within 6 weeks
- Previous thrombosis of the affected limb (secondary thrombosis)
- Varicosities/venous insufficiency Clinical, Etiologic, Anatomic, and Pathophysiologic (CEAP) classification C3 or higher
- Pregnancy
- Immobility (wheelchair dependent)
- Alanine aminotransferase (ALAT) \> 3 times normal range
- estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT00970619
Start Date
May 1 2010
End Date
November 1 2018
Last Update
March 6 2020
Active Locations (16)
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1
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
2
Academisch Medisch Centrum
Amsterdam, Netherlands
3
VuMC
Amsterdam, Netherlands
4
Nij Smellinghe
Drachten, Netherlands