MedTrace Logo

PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

NCT00182143 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3659

Last updated 2011-01-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of Low Molecular Weight Heparin (LMWH) (Fragmin, dalteparin) versus Unfractionated Heparin (UFH) on the primary outcome of proximal leg Deep Vein Thrombosis (DVT) diagnosed by compression ultrasound, and the secondary outcomes of Pulmonary Embolism (PE), bleeding, Heparin-Induced Thrombocytopenia (HIT), and objectively confirmed venous thrombosis at any site.

Conditions

  • Critical Illness
  • Deep Venous Thrombosis

Interventions

DRUG

LMWH (Fragmin, dalteparin)

Placebo AM dose (normal saline) and LMWH (Fragmin, dalteparin) 5000IU PM dose

DRUG

Unfractionated Heparin

5000 IU BID

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Canadian Critical Care Trials Group

    collaborator OTHER

  • Australian and New Zealand Intensive Care Society Clinical Trials Group

    collaborator NETWORK

  • McMaster University

    lead OTHER

Principal Investigators

  • Deborah J Cook, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Saudi Arabia
  • 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 NCT00182143 on ClinicalTrials.gov