Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
- Registration Number
- NCT00699465
- Lead Sponsor
- University of Oulu
- 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 safety of the European and American guideline recommendations.
* To provide an efficient and safe thromboprophylaxis for several weeks until the patient is able to walk.
- 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 stroke.
* The currently available guidelines state that while low doses of subcutaneous heparin or low-molecular-weight heparin may reduce VTE, it is possible that their effect is counterbalanced by an increase in hemorrhagic complications.
* It is still unclear when (if ever) low-molecular-weight-heparin should be safely initiated in ICH patients.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
- acute primary ICH
- > 17 years
- unable to walk
- admitted within 12 h after onset of ICH
- informed consent obtained
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 enoxaparin placebo Late enoxaparin 1 enoxaparin Early enoxaparin
- Primary Outcome Measures
Name Time Method The cumulative occurrence of confirmed VTE, defined as the composite of symptomatic or asymptomatic DVT, or symptomatic or fatal PE occurring during the treatment period. 90 days
- Secondary Outcome Measures
Name Time Method Cardiovascular death occurring within the treatment period 90 days Bleeding complications including rebleedings occurring within the treatment period 90 days Increase in ICH volume observed by head CT or at autopsy during the treatment period 90 days Death due to any cause occurring within the treatment period 90 days
Trial Locations
- Locations (1)
Department of Neurology, Oulu University Hospital
🇫🇮Oulu, Finland