PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients (PREVENTIHS)

September 9, 2021 updated by: Maurizio Paciaroni, University Of Perugia
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Perugia, Italy, 06126
        • Stroke Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With 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
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleedings
Time Frame: 90 days
symptomatic and asymptomatic intra and extracranial bleedings
90 days
Mortality
Time Frame: 90 days
mortality of any cause
90 days
Disability
Time Frame: 90 days

modified Rankin Scale (mRS) equal to and greater than 3.

0 - No symptoms.

  1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
  2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
  3. - Moderate disability. Requires some help, but able to walk unassisted.
  4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
  5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
  6. - Dead.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

March 1, 2020

Study Completion (ACTUAL)

March 1, 2020

Study Registration Dates

First Submitted

March 31, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENTIHS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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