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PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients (PREVENTIHS)

This study is currently recruiting participants.
Verified October 2017 by Maurizio Paciaroni, University Of Perugia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01573169
First Posted: April 6, 2012
Last Update Posted: October 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Maurizio Paciaroni, University Of Perugia
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Further study details as provided by Maurizio Paciaroni, University Of Perugia:

Primary Outcome Measures:
  • Symptomatic and asymptomatic venous thromboembolism [ Time Frame: 10 days ]
    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 ]
    symptomatic and asymptomatic intra and extracranial bleedings

  • mortality [ Time Frame: 90 days ]
    mortality of any cause

  • disability [ Time Frame: 90 days ]
    modified Rankin Scale (mRS) equal to and greater than 3


Estimated Enrollment: 406
Study Start Date: May 2012
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573169


Contacts
Contact: Maurizio Paciaroni, MD 0039 (0)75 5782765 maurizio.paciaroni@unipg.it

Locations
Italy
Stroke Unit Recruiting
Perugia, Italy, 06126
Contact: Maurizio Paciaroni         
Contact       maurizio.paciaroni@unipg.it   
Sponsors and Collaborators
University Of Perugia
  More Information

Publications:
Responsible Party: Maurizio Paciaroni, Principal Investigator, University Of Perugia
ClinicalTrials.gov Identifier: NCT01573169     History of Changes
Other Study ID Numbers: PREVENTIHS
First Submitted: March 31, 2012
First Posted: April 6, 2012
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Maurizio Paciaroni, University Of Perugia:
hemorrhagic stroke
venous thromboembolism
prevention

Additional relevant MeSH terms:
Venous Thromboembolism
Stroke
Thrombosis
Thromboembolism
Venous Thrombosis
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Hemorrhage
Pathologic Processes