PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-03-31

Brief Summary

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Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism. Intermittent pneumatic compression combined with elastic stockings have been shown to be superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism in patients with ICH because the use of anticoagulants may cause an enlargement of the hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization) will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke onset.

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Detailed Description

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Conditions

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Hemorrhagic Stroke Venous Thromboembolism Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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low weight molecular heparin

enoxaparin 0.4 ml subcutaneous per day

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke

standard therapy

Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization

Group Type PLACEBO_COMPARATOR

Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization

Intervention Type OTHER

placebo standard therapy

Interventions

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Enoxaparin

enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke

Intervention Type DRUG

Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization

placebo standard therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Intracranial spontaneous hemorrhage on brain CT scan
* Intracranial hemorrhage during treatment with oral anticoagulants
* Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for cerebellar hemorrhage).