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Clinical Trials/EUCTR2009-012387-13-GB
EUCTR2009-012387-13-GB
Active, not recruiting
Not Applicable

PROTECT - Prophylaxis of ThromboEmbolism in Critical Care Trial - PROTECT

McMaster University0 sites3,650 target enrollmentMarch 15, 2010

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.

Registry
who.int
Start Date
March 15, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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