Status:
TERMINATED
Long-term Treatment for Cancer Patients With Deep Venous Thrombosis or Pulmonary Embolism
Lead Sponsor:
University Medical Center Groningen
Conditions:
Venous Thromboembolism
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Background Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injecti...
Detailed Description
Venous thromboembolism (VTE), including deep venous thrombosis (DVT) and pulmonary embolism (PE), represents a major cause of morbidity and mortality in cancer patients. 1 The risk of VTE is increased...
Eligibility Criteria
Inclusion
- Patients with cancer and confirmed pulmonary embolism (PE) or deep vein thrombosis (DVT) of the leg who have been treated for minimally 6 and maximally 12 months with therapeutic doses of anticoagulants, i.e. LMWH or VKA or a new anticoagulant in a trial
- Written informed consent
- Indication for long-term anticoagulant therapy (e.g. because of metastasized disease, chemotherapy)
Exclusion
- Legal age limitations (country specific), minimum age at least 18 years
- Indications for anticoagulant therapy other than DVT or PE
- Any contraindication listed in the local labeling of LMWH or VKA
- Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding
- Life expectancy \<3 months
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01164046
Start Date
August 1 2010
End Date
July 1 2014
Last Update
December 3 2014
Active Locations (14)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20037
2
University Health Network
Toronto, Ontario, Canada
3
Medical Clinic Dresden University
Dresden, Germany
4
Ospedali Riuniti
Bergamo, Italy