Status:
UNKNOWN
Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
Lead Sponsor:
University of Oulu
Collaborating Sponsors:
University of Helsinki
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
* To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of VTE. * To assess the safety and efficacy of additional therapy with enoxaparin. * To compare the efficacy and...
Detailed Description
* Although it has been poorly investigated, the risk of VTE among patients with acute primary intracerebral hemorrhage is generally believed to be at least as high as among patients with ischemic stro...
Eligibility Criteria
Inclusion
- acute primary ICH
- \> 17 years
- unable to walk
- admitted within 12 h after onset of ICH
- informed consent obtained
Exclusion
- other type of ICH than acute primary intracerebral hemorrhage
- patients who need neurosurgery
- evidence of VTE at screening
- thrombolytic treatment within the preceding week
- major surgery or major trauma within the preceding 3 months
- life expectancy less than 3 months due to comorbid disorders
- confirmed malignant disease (cancer)
- hepatitis and/or liver cirrhosis
- renal failure
- infectious disease (HIV, endocarditis etc.)
- current of previous hematologic disease
- recent active and untreated gastric/duodenal ulcer
- allergy or known hypersensitivity to enoxaparin or heparins
- known hypersensitivity to benzyl alcohol
- women of childbearing age if pregnant
- participation in another study within the preceding 30 days
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00699465
Start Date
August 1 2008
End Date
December 1 2013
Last Update
July 2 2010
Active Locations (1)
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1
Department of Neurology, Oulu University Hospital
Oulu, Finland, 90029 OYS