PROphylaxis for ThromboEmbolism in Critical Care Trial (PROTECT)

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McMaster University
• Collaborators: Australian and New Zealand Intensive Care Society Clinical Trials Group; 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. Patient is >/= 18 years of age

2. Actual body weight is >/= 45 kg

3. Admission to ICU expected to be >/= 72 hours in duration

Exclusion Criteria:

1. Neurosurgery within last 3 months

2. Ischemic stroke within last 3 months

3. Intracranial hemorrhage within last 3 months

4. Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion

5. Major hemorrhage within last week unless definitively treated

6. Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening

7. Thrombocytopenia defined as platelet count

8. Other heparin contraindications (e.g., HIT, pregnancy, lactating)

9. Contraindication to blood products (e.g., Jehovah's Witness)

10. Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)

11. Limitation of life support, Life expectancy

12. Contamination (e.g., >/= 3 doses of LMWH during this ICU admission)

13. Lack of informed consent