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 because the information has not been verified recently.
Verified March 2009 by Azienda Ospedaliera Universitaria Policlinico.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Ospedaliera Universitaria Policlinico
ClinicalTrials.gov Identifier:
NCT00450645
First received: March 20, 2007
Last updated: March 3, 2009
Last verified: March 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Minor bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Death due to cancer [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450645

Contacts
Contact: Sergio Siragusa, MD + 39 091 655 4419 sergio.siragusa@unipa.it

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

No publications provided

Responsible Party: Sergio Siragusa, University Hospital of Palermo
ClinicalTrials.gov Identifier: NCT00450645     History of Changes
Other Study ID Numbers: 1/05
Study First Received: March 20, 2007
Last Updated: March 3, 2009
Health Authority: Italy: National Bioethics Committee

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

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
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 July 28, 2014