Intracerebral Hemorrhage
Conditions
Keywords
Thromboprophylaxis, Prevention of venous thromboembolism after ICH, Enoxaparin, Intermittent pneumatic compression
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.
Interventions
DRUGenoxaparin
20 mg enoxaparin (2 000 IU) s.c. will be given twice daily starting 24-48 h after onset of the stroke. Intermittent pneumatic compression will be started immediately after admission.
Placebo will be given s.c. twice daily starting 24-48 h after onset of the stroke for 2 days. Thereafter, 20 mg enoxaparin (2 000 IU) s.c. will be given twice daily. Intermittent pneumatic compression will be started immediately after admission.
Sponsors
University of Helsinki
University of Oulu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* acute primary ICH * \> 17 years * unable to walk * admitted within 12 h after onset of ICH * informed consent obtained
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Increase in ICH volume observed by head CT or at autopsy during the treatment period | 90 days |
| Cardiovascular death occurring within the treatment period | 90 days |
| Death due to any cause occurring within the treatment period | 90 days |
| Bleeding complications including rebleedings occurring within the treatment period | 90 days |
Countries
Finland
Contacts
Primary ContactMatti E Hillbom, MD, PhD
Backup ContactJuha T Huhtakangas, MD
Outcome results
None listed