Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

University of Oulu320 enrolled

Overview

* 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.

* 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

320

Conditions

Intracerebral Hemorrhage

Interventions

enoxaparinDRUG

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.

enoxaparin placeboDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Neurology, Oulu University Hospital

Oulu, Finland

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 90 days