NCT00699465

Brief Summary

  • 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 2, 2010

Status Verified

July 1, 2010

Enrollment Period

4.9 years

First QC Date

June 12, 2008

Last Update Submit

July 1, 2010

Conditions

Intracerebral Hemorrhage

Keywords

ThromboprophylaxisPrevention of venous thromboembolism after ICHEnoxaparinIntermittent pneumatic compression

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days

Secondary Outcomes (4)

  • Bleeding complications including rebleedings occurring within the treatment period

    90 days

  • Increase in ICH volume observed by head CT or at autopsy during the treatment period

    90 days

  • Cardiovascular death occurring within the treatment period

    90 days

  • Death due to any cause occurring within the treatment period

    90 days

Study Arms (2)

1

ACTIVE COMPARATOR

Early enoxaparin

Drug: enoxaparin

2

PLACEBO COMPARATOR

Late enoxaparin

Drug: enoxaparin placebo

Interventions

enoxaparinDRUG

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.

Also known as: Klexane, Kendall
1
enoxaparin placeboDRUG

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.

Also known as: Klexane, Kendall
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Oulu University Hospital

Oulu, 90029 OYS, Finland

RECRUITING

Related Publications (2)

  • Steiner T, Kaste M, Forsting M, Mendelow D, Kwiecinski H, Szikora I, Juvela S, Marchel A, Chapot R, Cognard C, Unterberg A, Hacke W. Recommendations for the management of intracranial haemorrhage - part I: spontaneous intracerebral haemorrhage. The European Stroke Initiative Writing Committee and the Writing Committee for the EUSI Executive Committee. Cerebrovasc Dis. 2006;22(4):294-316. doi: 10.1159/000094831. Epub 2006 Jul 28.

    PMID: 16926557BACKGROUND

  • Broderick J, Connolly S, Feldmann E, Hanley D, Kase C, Krieger D, Mayberg M, Morgenstern L, Ogilvy CS, Vespa P, Zuccarello M; American Heart Association; American Stroke Association Stroke Council; High Blood Pressure Research Council; Quality of Care and Outcomes in Research Interdisciplinary Working Group. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Stroke. 2007 Jun;38(6):2001-23. doi: 10.1161/STROKEAHA.107.183689. Epub 2007 May 3.

    PMID: 17478736BACKGROUND

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Matti E Hillbom, MD, PhD

    Oulu University Central Hospital, Department of Neurology

    STUDY CHAIR

  • Seppo S Juvela, MD, PhD

    Turku University Central Hospital, Department of Neurosurgery

    STUDY DIRECTOR

  • 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

  • Aimo Rissanen, MD, PhD

    Keski-Suomen Keskussairaala

    PRINCIPAL INVESTIGATOR

  • Heikki Numminen, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matti E Hillbom, MD, PhD

CONTACT

358-8-315-4518matti.hillbom@oulu.fi

Juha T Huhtakangas, MD

CONTACT

358-8-315-4032juha.huhtakangas@ppshp.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 18, 2008

Study Start

August 1, 2008

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

July 2, 2010

Record last verified: 2010-07

Locations

FI(1)