PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

Completed · Phase 3 · Has a placebo group

Conditions studied: Critical Illness, Deep Venous Thrombosis

In brief

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.

Key facts

Study ID

NCT00182143

Run by

McMaster University

People needed

3659

Starts

2006-05-01

Expected to finish

2010-06-01

Last updated by the study team

2011-01-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is >/= 18 years of age
• Actual body weight is >/= 45 kg
• Admission to ICU expected to be >/= 72 hours in duration

You may not qualify if…

• Neurosurgery within last 3 months
• Ischemic stroke within last 3 months
• Intracranial hemorrhage within last 3 months
• Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion
• Major hemorrhage within last week unless definitively treated
• Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening
• Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening
• Other heparin contraindications (e.g., HIT, pregnancy, lactating)
• Contraindication to blood products (e.g., Jehovah's Witness)
• Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)
• Limitation of life support, Life expectancy </= 14 days, or palliative care
• Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)
• Lack of informed consent

Where it is running

• St. John's Mercy Medical Center — St Louis, Missouri, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• MD Anderson — Houston, Texas, United States
• Blacktown Hospital — Blacktown, New South Wales, Australia
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Nepean Hospital — Penrith, New South Wales, Australia
• Wollongong Hospital — Wollongong, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia
• Flinders Hospital — Bedford Park, Victoria, Australia
• Bendigo Health Care — Bendigo, Victoria, Australia
• Box Hill Hospital — Box Hill, Victoria, Australia
• Monash Medical Center — Clayton, Victoria, Australia
• Dandenong Hospital — Dandenong, Victoria, Australia
• Frankston Hospital — Frankston, Victoria, Australia
• The Geelong Hospital — Geelong, Victoria, Australia
• Austin Hill Hospital — Heidelburg, Victoria, Australia
• Royal Melbourne Hospital — Melbourne, Victoria, Australia
• The Alfred Hospital — Melbourne, Victoria, Australia
• Royal North Shore Hospital — St Leonards, Australia
• UTI da Enfermaria de Clinical Medica do Hospital — São Paulo, Brazil, Brazil
• Hospitalar Santa Casa — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Moinhos de Vento — Porto Alegre, Rs Cep, Brazil
• Hospital ProCardiaco — Rio de Janeiro, Brazil
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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