Status:
COMPLETED
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Canadian Critical Care Trials Group
Conditions:
Critically Ill
Deep Venous Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
PROTECT Pilot objective is to assess: 1) the feasibility of timely enrollment and complete, blinded study drug administration, 2) the bioaccumulation of LMWH in patients with acquired renal insufficie...
Detailed Description
Prophylaxis for Thromboembolism in Critical Care Trial: PROTECT pilot Study Background: Critically ill patients have an increased risk of deep venous thrombosis (DVT) due to their acute illness, pro...
Eligibility Criteria
Inclusion
- Admission to ICU
- Men and women greater than 18 years of age or older
- Expected to remain in ICU admission greater than 72 hours
Exclusion
- Contraindications to LMWH or blood products
- Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients,
- Uncontrolled hypertension as defined by a systolic blood pressure \> 180 mmHg or a diastolic blood pressure \> 110 mmHg,
- Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months,
- Coagulopathy as defined by INR \>2 times upper limit of normal \[ULN\], or PTT \>2 times ULN,
- Renal insufficiency as defined by a creatinine clearance \<30ml/min,
- A need for oral or intravenous or subcutaneous therapeutic anticoagulation,
- Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT),
- Receipt of \>2 doses of UFH or LMWH in ICU,
- Pregnant or lactating,
- Withdrawal of life support or limitation of life support,
- Prior enrollment in this trial
- Prior enrollment into a related RCT
- Thrombocytopenia defined platelet count \< 100 x 109/L,
- Bilateral lower limb amputation,
- Allergy to pork or pork products
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00182364
Start Date
February 1 2003
End Date
February 1 2004
Last Update
November 17 2006
Active Locations (16)
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1
Royal Alfred Hospital
Melbourne, Australia, 3181
2
Royal North Shore Hospital of Sydney
Sydney, Australia, 2065
3
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, Canada, B3H 3A7
4
Hamilton Health Science Centre - Hamilton General Hospital
Hamilton, Ontario, Canada, L8N 3Z5