Status:
COMPLETED
Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients
Lead Sponsor:
Medical University of Vienna
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 gene...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
May 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00375076
Start Date
June 1 2006
End Date
May 1 2008
Last Update
September 18 2009
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090