ACTRN12606000090516
Completed
Phase 3
A randomized phase III study to compare the effects of low-molecular weight heparin and unfractionated heparin in the prevention of proximal deep vein thrombosis in a critically ill population
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Thromboembolism
- Sponsor
- McMaster University
- Enrollment
- 3650
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Actual body weight \>45 kgAdmission to ICU expected to be \>72 hours durationEligible for either UFH or LWMH thromboprophylaxis.
Exclusion Criteria
- •Contraindication to prophylactic heparinNeurosurgery within last 3 monthsIschemic or hemorrhagic stroke within last 3 monthsIntracranial hemorrhage, within last 3 monthsSystolic blood pressure (SBP) \> 180 mmHg, diastolic blood pressure \> 110 mmHg for \> 12 hours requiring vasoactive drug infusionMajor hemorrhage within the last week unless definitively treated (e.g., AAA repair)Coagulopathy (INR \> 2 x ULN, or PTT \> 2 x ULN)Thrombocytopenia (platelet count \< 75 x 109/L)Other heparin contraindications (e.g., HIT, pregnancy)Contraindications to blood products (e.g., Jehovah’s Witness)Unable to perform lower limb ultrasound (e.g., severe distal extremity burns)Limitation of life support (life expectancy \< 7 days, or palliative care Contamination (e.g., \> 3 days of any UFH or LMWH prophylaxis during this ICU admission).
Outcomes
Primary Outcomes
Not specified
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