Overview
PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT Pilot)
Status:
Completed
Completed
Trial end date:
2004-02-01
2004-02-01
Target enrollment:
0
0
Participant gender:
All
All
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 insufficiency and its association with bleeding, 3) the feasibility of scheduled twice weekly lower limb ultrasounds, and 4) recruitment rates for a future randomized trial.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hamilton Health Sciences CorporationCollaborators:
Canadian Critical Care Trials Group
Canadian Institutes of Health Research (CIHR)Treatments:
Calcium heparin
Dalteparin
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Criteria
Inclusion Criteria:1. Admission to ICU
2. Men and women greater than 18 years of age or older
3. Expected to remain in ICU admission greater than 72 hours
Exclusion Criteria:
1. Contraindications to LMWH or blood products
2. Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients,
3. Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a
diastolic blood pressure > 110 mmHg,
4. Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months,
5. Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times
ULN,
6. Renal insufficiency as defined by a creatinine clearance <30ml/min,
7. A need for oral or intravenous or subcutaneous therapeutic anticoagulation,
8. Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT),
9. Receipt of >2 doses of UFH or LMWH in ICU,
10. Pregnant or lactating,
11. Withdrawal of life support or limitation of life support,
12. Prior enrollment in this trial
13. Prior enrollment into a related RCT
14. Thrombocytopenia defined platelet count < 100 x 109/L,
15. Bilateral lower limb amputation,
16. Allergy to pork or pork products