MedTrace Logo

EXCLAIM:Extended Prophylaxis for Venous ThromboEmbolism (VTE) in Acutely Ill Medical Patients With Prolonged Immobilization

NCT00077753 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4726

Last updated 2011-01-11

No results posted yet for this study

Summary

Primary objective:

* To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd

Secondary objectives:

* To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis
* To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study
* To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:

* Major and minor hemorrhage
* Heparin induced thrombocytopenia
* Serious adverse events
* To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

enoxaparin sodium

Sponsors & Collaborators

Principal Investigators

  • Luc Sagnard · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Primary Completion
2006-10-31
Completion
2007-02-28

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Colombia
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Mexico
  • Poland
  • Russia
  • South Africa
  • Spain
  • Tunisia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00077753 on ClinicalTrials.gov