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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00375076
Recruitment Status : Completed
First Posted : September 12, 2006
Last Update Posted : September 18, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: enoxaparin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Prevention of Venous Thrombosis in Cancer Patients: A Prospective, Randomized, Double-blind Study Comparing Two Different Dosages of Low-molecular Weight Heparin
Study Start Date : June 2006
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Heparin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sabine Eichinger, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00375076     History of Changes
Other Study ID Numbers: ODEXA1
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action