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Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Principal Investigator

Sabine Eichinger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Vienna

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

ODEXA1

NCT ID:

NCT00375076

Start Date:

June 2006

Completion Date:

May 2008

Related Keywords:

  • Cancer

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