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

Phase 3

Completed

• Conditions: Cancer

• Registration Number: NCT00375076
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-11
• Study First Posted: 2006-09-12
• Study Completion: 2008-05
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-17
• Last Update Posted: 2009-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria