NCT00450645

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 4, 2009

Status Verified

March 1, 2009

Enrollment Period

4 years

First QC Date

March 20, 2007

Last Update Submit

March 3, 2009

Conditions

Deep Vein ThrombosisCancer

Keywords

CancerResidual vein thrombosisLow Molecular Weight HeparinOptimal duration

Outcome Measures

Primary Outcomes (1)

  • Recurrent Deep Vein Thrombosis and/or Pulmonary Embolism

    30 days

Secondary Outcomes (2)

  • Minor bleeding

    30 days

  • Death due to cancer

    30 days

Interventions

low molecular weight heparinDRUG

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hematology and Haemostasi/Thrombosis Unit, University of Palermo

Palermo, 90127, Italy

RECRUITING

Related Publications (1)

  • Napolitano M, Saccullo G, Malato A, Sprini D, Ageno W, Imberti D, Mascheroni D, Bucherini E, Gallucci P, D'Alessio A, Prantera T, Spadaro P, Rotondo S, Di Micco P, Oriana V, Urbano O, Recchia F, Ghirarduzzi A, Lo Coco L, Mancuso S, Casuccio A, Rini GB, Siragusa S. Optimal duration of low molecular weight heparin for the treatment of cancer-related deep vein thrombosis: the Cancer-DACUS Study. J Clin Oncol. 2014 Nov 10;32(32):3607-12. doi: 10.1200/JCO.2013.51.7433. Epub 2014 Sep 29.

    PMID: 25267738DERIVED

MeSH Terms

Conditions

Venous ThrombosisNeoplasms

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Sergio Siragusa, MD

    University Hospital of Palermo

    STUDY CHAIR

Central Study Contacts

Sergio Siragusa, MD

CONTACT

+ 39 091 655 4419sergio.siragusa@unipa.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 20, 2007

First Posted

March 22, 2007

Study Start

March 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2011

Last Updated

March 4, 2009

Record last verified: 2009-03

Locations

IT(1)