Prevention of venous thrombosis in cancer patients: A prospective, randomized, double-blind study comparing two different dosages of low-molecular weight heparin
- Conditions
- cancer patients
- Registration Number
- EUCTR2005-002068-27-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 94
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
•respiratory failure
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•indication for LMWH or UFH at therapeutic dosages (e.g. for acute venous thromboembolism)
•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
•surgery within the last 4 weeks
•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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to investigate the effect of LMWH on hemostatic system activation, as measured by the levels of F1+2 and D-dimer, in cancer patients<br>to compare the effects of two different dosages of enoxaparin (40 mg od sc and 80 mg od sc) on these markers of hemostatic system activation in cancer patients<br><br>;Secondary Objective: to investigate the effects of these two different regimens of enoxaparin on the generation and composition of MPs in cancer patients;Primary end point(s):
- Secondary Outcome Measures
Name Time Method