Status:
COMPLETED
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Conditions:
Critical Illness
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Th...
Detailed Description
PROTECT: The PROphylaxis for ThromboEmbolism in Critical Care Trial. Background: Critically ill patients have an increased risk of deep venous thrombosis (DVT) due to their acute illness, procedures ...
Eligibility Criteria
Inclusion
- Patient is \>/= 18 years of age
- Actual body weight is \>/= 45 kg
- Admission to ICU expected to be \>/= 72 hours in duration
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
3659 Patients enrolled
Trial Details
Trial ID
NCT00182143
Start Date
May 1 2006
End Date
June 1 2010
Last Update
January 10 2011
Active Locations (67)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905
2
St. John's Mercy Medical Center
St Louis, Missouri, United States, 63141
3
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
4
MD Anderson
Houston, Texas, United States, 77030