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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00375076
• Other study ID #: ODEXA1
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2006
• Last updated: September 17, 2009
• Start date: June 2006
• Est. completion date: May 2008

Study information

• Verified date: September 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• enoxaparin

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria,