EUCTR2009-012387-13-GB
Active, not recruiting
Not Applicable
PROTECT - Prophylaxis of ThromboEmbolism in Critical Care Trial - PROTECT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critically ill patients who require admission to the intensive care unit and need pharmacologic thromboprophylaxis
- Sponsor
- McMaster University
- Enrollment
- 3650
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion Criteria:
- •1\.Men or women \>18 years of age
- •2\. Actual body weight \>45 kg
- •3\.Admission to intensive care unit expected to be \>72 hours duration
- •4\. Eligible for either unfractionated heparin or low molecular weight heparin thromboprophylaxis
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Contraindication to prophylactic heparin
- •1\.Neurosurgery within last 3 months
- •2\.Ischemic or hemorrhagic stroke within last 3 months
- •3\.Intracranial hemorrhage, within last 3 months
- •4\.Systolic blood pressure \> 180 mmHg, diastolic blood pressure \> 110 mmHg for \> 12 hours requiring vasoactive drug infusion
- •5\.Major hemorrhage within the last week unless definitively treated
- •6\.Coagulopathy (INR \> 2 x ULN, or PTT \> 2 x ULN)
- •7\.Thrombocytopenia
- •8\. Other heparin contraindications (e.g., HIT, pregnancy)
- •9\.Contraindications to blood products (e.g., Jehovah’s Witness)
Outcomes
Primary Outcomes
Not specified
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