PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients (PREVENTIHS)

University Of Perugia

Status and phase: Terminated; Phase 3

Conditions: Venous Thromboembolism; Deep Venous Thrombosis; Hemorrhagic Stroke

Treatments: Drug: Enoxaparin; Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT01573169

PREVENTIHS

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups, including a placebo group

low weight molecular heparin

Experimental group

Description:

enoxaparin 0.4 ml subcutaneous per day

Treatment:

Drug: Enoxaparin

standard therapy

Placebo Comparator group

Description:

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

Treatment:

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