Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients
Information source: Medical University of Vienna
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer
Intervention: enoxaparin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Sabine Eichinger, MD, Principal Investigator, Affiliation: Medical University of Vienna
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.
Clinical Details
Official title: Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Medical University of Vienna, Vienna 1090, Austria
Additional Information
Starting date: June 2006
Last updated: September 17, 2009
|
