NCT00375076CompletedPhase 3
Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Locations
- 2
Study Overview
Brief Summary
In a prospective, randomized, double-blind trial, the effects of two different dosages of LMWH (5000 anti-Xa U od sc and 10 000 anti-Xa U od sc daily) on markers of hemostatic system and thrombin generation will be investigated in non-surgical cancer patients will be investigated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients (> 18 years) with active cancer and at least one of the following indications for thromboprophylaxis with LMWH:
- •Immobilization
- •History of VTE
- •Acute inflammation
- •Heart failure (NYHA class III or IV)
- •Respiratory failure
Exclusion Criteria
- •Indication for LMWH or UFH at therapeutic dosages
- •Treatment with antithrombotics (vitamin K antagonists, acetylsalicylic acid, clopidogrel) for reasons other than prevention of VTE (e.g. atrial fibrillation, myocardial infarction)
- •Contraindication for the treatment with LMWH
- •Major surgery within the last 4 weeks; minor surgery within the last week
- •Thrombocytopenia (< 100.000/μl)
- •Prolonged prothrombin time
- •Prolonged activated partial thromboplastin time (aPTT)
- •History of heparin-induced thrombocytopenia
- •Bodyweight < 50 kg or > 100 kg
- •Renal insufficiency (creatinine > 2 mg/dl)
Investigators
Study Sites (2)
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