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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Azienda Ospedaliera Universitaria Policlinico.
Recruitment status was:  Recruiting
Information provided by:
Azienda Ospedaliera Universitaria Policlinico Identifier:
First received: March 20, 2007
Last updated: March 3, 2009
Last verified: March 2009
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 Intervention Phase
Deep Vein Thrombosis Cancer Drug: low molecular weight heparin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Azienda Ospedaliera Universitaria Policlinico:

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

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

Estimated Enrollment: 300
Study Start Date: March 2005
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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)
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00450645

Contact: Sergio Siragusa, MD + 39 091 655 4419

Hematology and Haemostasi/Thrombosis Unit, University of Palermo Recruiting
Palermo, Italy, 90127
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico
Study Chair: Sergio Siragusa, MD University Hospital of Palermo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sergio Siragusa, University Hospital of Palermo Identifier: NCT00450645     History of Changes
Other Study ID Numbers: 1/05
Study First Received: March 20, 2007
Last Updated: March 3, 2009

Keywords provided by Azienda Ospedaliera Universitaria Policlinico:
Residual vein thrombosis
Low Molecular Weight Heparin
Optimal duration

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017