PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Venous Thromboembolism Clinical Trial

— PREVENTIHS  

Official title:

PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01573169
• Other study ID #: PREVENTIHS
• Status: Terminated
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: March 2020

Study information

• Verified date: September 2021
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Hemorrhagic Stroke
• Stroke
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
Italy	Stroke Unit	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Paciaroni M, Agnelli G, Venti M, Alberti A, Acciarresi M, Caso V. Efficacy and safety of anticoagulants in the prevention of venous thromboembolism in patients with acute cerebral hemorrhage: a meta-analysis of controlled studies. J Thromb Haemost. 2011 May;9(5):893-8. doi: 10.1111/j.1538-7836.2011.04241.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bleedings	symptomatic and asymptomatic intra and extracranial bleedings	90 days
Secondary	Mortality	mortality of any cause	90 days
Secondary	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