Comparison of Two Different Dosages of Low-molecular Weight Heparin in Cancer Patients

Medical University of Vienna

Status and phase: Completed; Phase 3

Conditions: Cancer

Treatments: Drug: enoxaparin

Study type: Interventional

Funder types: Other

Identifiers

NCT00375076

ODEXA1

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)