Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

University of Oulu

Status and phase: Unknown; Phase 4

Conditions: Intracerebral Hemorrhage

Treatments: Drug: enoxaparin; Drug: enoxaparin placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00699465

EUDRACT 2007-006206-24

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Early enoxaparin

Treatment:

Drug: enoxaparin

2

Placebo Comparator group

Description:

Late enoxaparin

Treatment:

Drug: enoxaparin placebo