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Residual Vein Thrombosis and the Optimal Duration of Low Molecular Weight Heparin in Cancer Patients With Deep Vein Thrombosis (Cancer-DACUS)

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. Identifier: NCT00450645
Recruitment Status : Unknown
Verified March 2009 by Azienda Ospedaliera Universitaria Policlinico.
Recruitment status was:  Recruiting
First Posted : March 22, 2007
Last Update Posted : March 4, 2009
Information provided by:
Azienda Ospedaliera Universitaria Policlinico

Brief Summary:
The duration of anticoagulant treatment in cancer patients with Deep Vein Thrombosis (DVT) of the lower limbs is still uncertain. The present study addresses the possible role of the Residual Vein Thrombosis (RVT) for establishing the optimal duration of Low Molecular Weight Heparin (LMWH). Patients with a first episode of symptomatic unprovoked or provoked proximal DVT will received LMWHs for 6 months; RVT, ultrasonographically-detected, will be then assessed. Patients without RVT stop LMWH, whereas those with RVT will be randomized to either stop or continue OAT for additional 6 months. Patients were followed-up at least 1 year after anticoagulant discontinuation focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Cancer Drug: low molecular weight heparin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Residual Vein Thrombosis Establishes the Optimal Duration of Low Molecular Weight Heparins in Cancer Patients With Deep Vein Thrombosis of the Lower Limbs
Study Start Date : March 2005
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: low molecular weight heparin
    LMWH were continued for additional 6 months after detection of residual vein thrombosis (6 months after the index deep vein thrombosis) in patients randomized to group A. LMWH are stopped in patients randomized to group B or in those patients without residual vein thrombosis after 6 months from the index DVT. Dosage of LMWH are 75% of the therapeutic dosage (almost 1 mg/Kg every 12 hours)

Primary Outcome Measures :
  1. Recurrent Deep Vein Thrombosis and/or Pulmonary Embolism [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Minor bleeding [ Time Frame: 30 days ]
  2. Death due to cancer [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Cancer patients with a first episode of symptomatic proximal DVT of the lower limbs
  • No signs of unstable pulmonary embolism

Exclusion Criteria:

  • Indication to antithrombotic therapy/OAT for > 6 months (i.e. valvular prothesis, atrial fibrillation etc.)
  • Previous DVT/PE
  • Hypersensitivity to contrast media
  • Pregnancy
  • Life expectancy < 1 year
  • Patients who are unable to fulfill study requirements as for repeated clinical controls

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 identifier (NCT number): NCT00450645

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Contact: Sergio Siragusa, MD + 39 091 655 4419

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Hematology and Haemostasi/Thrombosis Unit, University of Palermo Recruiting
Palermo, Italy, 90127
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico
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Study Chair: Sergio Siragusa, MD University Hospital of Palermo
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sergio Siragusa, University Hospital of Palermo Identifier: NCT00450645    
Other Study ID Numbers: 1/05
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: March 4, 2009
Last Verified: March 2009
Keywords provided by Azienda Ospedaliera Universitaria Policlinico:
Residual vein thrombosis
Low Molecular Weight Heparin
Optimal duration
Additional relevant MeSH terms:
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Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action