PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

Last updated: September 9, 2021
Sponsor: University Of Perugia
Overall Status: Terminated

Phase

3

Condition

Venous Thrombosis

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT01573169
PREVENTIHS
  • Ages > 18
  • All Genders

Study 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

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 forcerebellar hemorrhage).

Exclusion

Exclusion Criteria:

  • cerebral hemorrhage due to intracranial vascular malformation
  • rebleeding on CT scan after 72 hours from stroke (before randomization)

Study Design

Total Participants: 73
Study Start date:
May 01, 2012
Estimated Completion Date:
March 31, 2020

Connect with a study center

  • Stroke Unit

    Perugia, 06126
    Italy

    Site Not Available

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