PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Phase 3

Terminated

• Conditions: Hemorrhagic Stroke; Venous Thromboembolism; Deep Venous Thrombosis
• Interventions: Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization; Drug: Enoxaparin

• Registration Number: NCT01573169
• Lead Sponsor: University Of Perugia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-31
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Study Start: 2012-05
• Primary Completion: 2020-03
• Study Completion: 2020-03
• Results First Submitted: 2021-01-03
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-09
• Last Update Submitted: 2021-09-09
• Results First Posted: 2021-09-10
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard therapy	Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization	Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization
low weight molecular heparin	Enoxaparin	enoxaparin 0.4 ml subcutaneous per day

Primary Outcome Measures

Name	Time	Method
Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism	10 days	Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination

Secondary Outcome Measures

Name	Time	Method
Bleedings	90 days	symptomatic and asymptomatic intra and extracranial bleedings
Mortality	90 days	mortality of any cause
Disability	90 days	modified Rankin Scale (mRS) equal to and greater than 3.; 0 - No symptoms.; 1. - No significant disability. Able to carry out all usual activities, despite some symptoms.; 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; 3. - Moderate disability. Requires some help, but able to walk unassisted.; 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; 6. - Dead.

Trial Locations

Locations (1)

Stroke Unit; 🇮🇹 Perugia, Italy