Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

July 1, 2010 updated by: University of Oulu

A Double-blind Randomized Trial to Compare the Efficacy of Intermittent Pneumatic Compression (IPC) With and Without Early Anticoagulant Treatment for Prevention of Venous Thromboembolism (VTE) in Patients With Acute Primary Intracerebral Hemorrhage (ICH)

  • To evaluate the efficacy of using IPC during the acute phase of ICH in the prevention of VTE.
  • To assess the safety and efficacy of additional therapy with enoxaparin.
  • To compare the efficacy and safety of the European and American guideline recommendations.
  • To provide an efficient and safe thromboprophylaxis for several weeks until the patient is able to walk.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Although it has been poorly investigated, the risk of VTE among patients with acute primary intracerebral hemorrhage is generally believed to be at least as high as among patients with ischemic stroke.
  • The currently available guidelines state that while low doses of subcutaneous heparin or low-molecular-weight heparin may reduce VTE, it is possible that their effect is counterbalanced by an increase in hemorrhagic complications.
  • It is still unclear when (if ever) low-molecular-weight-heparin should be safely initiated in ICH patients.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Finland
      • Oulu, Finland, 90029 OYS
        • Recruiting
        • Department of Neurology, Oulu University Hospital
        • Contact:
        • Sub-Investigator:
          • Sami T Tetri, MD
        • Sub-Investigator:
          • Michaela Bode, MD, PhD
        • Sub-Investigator:
          • Pertti Saloheimo, MD, PhD
        • Sub-Investigator:
          • Eeva-Riitta Savolainen, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Tarja H Haapaniemi, MD, PhD

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute primary ICH
  • > 17 years
  • unable to walk
  • admitted within 12 h after onset of ICH
  • informed consent obtained

Exclusion Criteria:

  • other type of ICH than acute primary intracerebral hemorrhage
  • patients who need neurosurgery
  • evidence of VTE at screening
  • thrombolytic treatment within the preceding week
  • major surgery or major trauma within the preceding 3 months
  • life expectancy less than 3 months due to comorbid disorders
  • confirmed malignant disease (cancer)
  • hepatitis and/or liver cirrhosis
  • renal failure
  • infectious disease (HIV, endocarditis etc.)
  • current of previous hematologic disease
  • recent active and untreated gastric/duodenal ulcer
  • allergy or known hypersensitivity to enoxaparin or heparins
  • known hypersensitivity to benzyl alcohol
  • women of childbearing age if pregnant
  • participation in another study within the preceding 30 days

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Early enoxaparin
Drug: enoxaparin
20 mg enoxaparin (2 000 IU) s.c. will be given twice daily starting 24-48 h after onset of the stroke. Intermittent pneumatic compression will be started immediately after admission.
Other Names:
  • Klexane
  • Kendall
Placebo Comparator: 2
Late enoxaparin
Drug: enoxaparin placebo
Placebo will be given s.c. twice daily starting 24-48 h after onset of the stroke for 2 days. Thereafter, 20 mg enoxaparin (2 000 IU) s.c. will be given twice daily. Intermittent pneumatic compression will be started immediately after admission.
Other Names:
  • Klexane
  • Kendall

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The cumulative occurrence of confirmed VTE, defined as the composite of symptomatic or asymptomatic DVT, or symptomatic or fatal PE occurring during the treatment period.
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular death occurring within the treatment period
Time Frame: 90 days
90 days
Death due to any cause occurring within the treatment period
Time Frame: 90 days
90 days
Bleeding complications including rebleedings occurring within the treatment period
Time Frame: 90 days
90 days
Increase in ICH volume observed by head CT or at autopsy during the treatment period
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

University of Oulu

Collaborators

University of Helsinki

Investigators

  • Study Chair: Matti E Hillbom, MD, PhD, Oulu University Central Hospital, Department of Neurology
  • Study Director: Seppo S Juvela, MD, PhD, Turku University Central Hospital, Department of Neurosurgery
  • Principal Investigator: Aimo Rissanen, MD, PhD, Keski-Suomen Keskussairaala
  • Principal Investigator: Turgut Tatlisumak, MD, PhD, Helsinki University Central Hospital, Department of Neurology
  • Principal Investigator: Liisa K Luostarinen, MD, PhD, Päijät-Häme Central Hospital, Department of Neurology
  • Principal Investigator: Heikki Numminen, MD, PhD, Tampere University Hospital

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

August 1, 2008

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 2, 2010

Last Update Submitted That Met QC Criteria

July 1, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT 2007-006206-24

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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