Clinical trial NCT01573169: PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Official title: PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hemorrhagic Stroke
Venous Thromboembolism
Deep Venous Thrombosis
Keywords: hemorrhagic stroke
venous thromboembolism
prevention
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2012-04-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism
timeFrame: 10 days
Secondary outcomes:
measure: Bleedings
timeFrame: 90 days
measure: Mortality
timeFrame: 90 days
measure: Disability
timeFrame: 90 days
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Stroke Unit
Study officials:
References:
citation: 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.
citation: Paciaroni M, Agnelli G, Alberti A, Becattini C, Guercini F, Martini G, Tassi R, Marotta G, Venti M, Acciarresi M, Mosconi MG, Marcheselli S, Fratticci L, D'Amore C, Ageno W, Versino M, De Lodovici ML, Carimati F, Pezzini A, Padovani A, Corea F, Scoditti U, Denti L, Tassinari T, Silvestrelli G, Ciccone A, Caso V. PREvention of VENous Thromboembolism in Hemorrhagic Stroke Patients - PREVENTIHS Study: A Randomized Controlled Trial and a Systematic Review and Meta-Analysis. Eur Neurol. 2020;83(6):566-575. doi: 10.1159/000511574. Epub 2020 Nov 13.