PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients (PREVENTIHS)

This study has suspended participant recruitment.
(The trial has been momentarily suspended after the randomization of 38 patients due to a lack of funding.)
Sponsor:
Information provided by (Responsible Party):
Maurizio Paciaroni, University Of Perugia
ClinicalTrials.gov Identifier:
NCT01573169
First received: March 31, 2012
Last updated: July 20, 2014
Last verified: July 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Stroke Unit
Perugia, Italy, 06126
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
Study First Received: March 31, 2012
Last Updated: July 20, 2014
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:
Venous Thrombosis
Venous Thromboembolism
Stroke
Cerebral Infarction
Thromboembolism
Thrombosis
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 August 28, 2014