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PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients

NCT01573169 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2021-09-10

Study results available
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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.

Conditions

  • Hemorrhagic Stroke
  • Venous Thromboembolism
  • Deep Venous Thrombosis

Interventions

DRUG

Enoxaparin

enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke

OTHER

Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization

placebo standard therapy

Sponsors & Collaborators

  • University Of Perugia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01573169 on ClinicalTrials.gov