MedTrace Logo

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

NCT00450645 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2009-03-04

No results posted yet for this study

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Policlinico

    lead OTHER

Principal Investigators

  • Sergio Siragusa, MD · University Hospital of Palermo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2009-03-31
Completion
2011-03-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00450645 on ClinicalTrials.gov