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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

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)