CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,659 enrolled
Drug / intervention
LMWH (Fragmin, dalteparin) +1 moredrug
Likely dose
LMWH (Fragmin, dalteparin) 5000IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00182143
NCT00182143Phase 3Completed
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PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

McMaster University·interventional·Posted Sep 16, 2005·Updated Jan 10, 2011

In Brief

A Phase 3 clinical trial evaluating LMWH (Fragmin, dalteparin) and Unfractionated Heparin for Critical Illness and Deep Venous Thrombosis. Completed, enrolled 3,659 participants across 67 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Illness, Deep Venous Thrombosis
CountriesAustralia, Brazil, Canada, Saudi Arabia, United Kingdom, United States
CollaboratorsCanadian Institutes of Health Research (CIHR), Canadian Critical Care Trials Group, Australian and New Zealand Intensive Care Society Clinical Trials Group

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartMay 1, 2006
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

LMWH (Fragmin, dalteparin)drug

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

Unfractionated Heparindrug

5000 IU BID