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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00375076
First received: September 11, 2006
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Cancer
 Drug: enoxaparin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Study Start Date: June 2006
Study Completion Date: May 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375076

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Sabine Eichinger, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Sabine Eichinger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00375076     History of Changes
Other Study ID Numbers: ODEXA1
Study First Received: September 11, 2006
Last Updated: September 17, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013