NCT01573169

PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: University Of Perugia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemorrhagic Stroke
• Venous Thromboembolism
• Deep Venous Thrombosis

Interventions

Type	Name	Description
DRUG	Enoxaparin	enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke
OTHER	Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization	placebo standard therapy

Timeline

• Start date: 2012-05-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2012-04-06
• Last updated: 2021-09-10
• Results posted: 2021-09-10

Locations

1 site across 1 country: Italy