PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Study Overview
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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.

Official Title
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PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Conditions
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Hemorrhagic Stroke, Venous Thromboembolism, Deep Venous Thrombosis

Intervention / Treatment
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* Drug: Enoxaparin
* Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization


Participation Criteria
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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). Exclusion Criteria: cerebral hemorrhage due to intracranial vascular malformation rebleeding on CT scan after 72 hours from stroke (before randomization)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low weight molecular heparin<br>enoxaparin 0.4 ml subcutaneous per day | Drug: Enoxaparin<br>* enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke<br>|
| Placebo Comparator: standard therapy<br>Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization | Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization<br>* placebo standard therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism | Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleedings | symptomatic and asymptomatic intra and extracranial bleedings | 90 days | 
| Mortality | mortality of any cause | 90 days | 
| Disability | modified Rankin Scale (mRS) equal to and greater than 3. 0 - No symptoms. - No significant disability. Able to carry out all usual activities, despite some symptoms. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. - Moderate disability. Requires some help, but able to walk unassisted. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. - Dead. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemorrhagic stroke, venous thromboembolism, prevention