PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients (PREVENTIHS)

This study is currently recruiting participants.

Verified May 2012 by University Of Perugia

Sponsor:

Information provided by (Responsible Party):

Maurizio Paciaroni, University Of Perugia

ClinicalTrials.gov Identifier:

NCT01573169

First received: March 31, 2012

Last updated: May 30, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hemorrhagic Stroke Venous Thromboembolism Deep Venous Thrombosis	Drug: Enoxaparin Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Enoxaparin sodium

U.S. FDA Resources

Further study details as provided by University Of Perugia:

Primary Outcome Measures:

Symptomatic and asymptomatic venous thromboembolism [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination

Secondary Outcome Measures:

Bleedings [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
symptomatic and asymptomatic intra and extracranial bleedings
mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
mortality of any cause
disability [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
modified Rankin Scale (mRS) equal to and greater than 3

Estimated Enrollment:	406
Study Start Date:	May 2012
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: low weight molecular heparin enoxaparin 0.4 ml subcutaneous per day	Drug: Enoxaparin enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke
Placebo Comparator: standard therapy Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization	Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization placebo standard therapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573169

Contacts

Contact: Maurizio Paciaroni, MD

0039 (0)75 5782765

mpaciaroni@med.unipg.it

Locations

Italy
Stroke Unit	Recruiting
Perugia, Italy, 06126
Contact: Maurizio Paciaroni
Contact mpaciaroni@med.unipg.it

Sponsors and Collaborators

University Of Perugia

More Information

Publications:

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.

Responsible Party:	Maurizio Paciaroni, Principal Investigator, University Of Perugia
ClinicalTrials.gov Identifier:	NCT01573169 History of Changes
Other Study ID Numbers:	PREVENTIHS
Study First Received:	March 31, 2012
Last Updated:	May 30, 2012
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by University Of Perugia:

hemorrhagic stroke
venous thromboembolism
prevention

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction

Brain Ischemia
Embolism and Thrombosis
Hemorrhage
Pathologic Processes
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013

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