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Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

Primary Purpose

Intracerebral Hemorrhage

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
enoxaparin
enoxaparin placebo
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intracerebral Hemorrhage focused on measuring Thromboprophylaxis, Prevention of venous thromboembolism after ICH, Enoxaparin, Intermittent pneumatic compression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Oulu University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Early enoxaparin

Late enoxaparin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2008
Last Updated
July 1, 2010
Sponsor
University of Oulu
Collaborators
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT00699465
Brief Title
Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oulu
Collaborators
University of Helsinki

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage
Keywords
Thromboprophylaxis, Prevention of venous thromboembolism after ICH, Enoxaparin, Intermittent pneumatic compression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Early enoxaparin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Late enoxaparin
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Other Intervention Name(s)
Klexane, Kendall
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
enoxaparin placebo
Other Intervention Name(s)
Klexane, Kendall
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Bleeding complications including rebleedings occurring within the treatment period
Time Frame
90 days
Title
Increase in ICH volume observed by head CT or at autopsy during the treatment period
Time Frame
90 days
Title
Cardiovascular death occurring within the treatment period
Time Frame
90 days
Title
Death due to any cause occurring within the treatment period
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matti E Hillbom, MD, PhD
Phone
358-8-315-4518
Email
matti.hillbom@oulu.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Juha T Huhtakangas, MD
Phone
358-8-315-4032
Email
juha.huhtakangas@ppshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matti E Hillbom, MD, PhD
Organizational Affiliation
Oulu University Central Hospital, Department of Neurology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Seppo S Juvela, MD, PhD
Organizational Affiliation
Turku University Central Hospital, Department of Neurosurgery
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Turgut Tatlisumak, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital, Department of Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liisa K Luostarinen, MD, PhD
Organizational Affiliation
Päijät-Häme Central Hospital, Department of Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aimo Rissanen, MD, PhD
Organizational Affiliation
Keski-Suomen Keskussairaala
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heikki Numminen, MD, PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029 OYS
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matti E Hillbom, professor
Phone
358-8-315-4518
Email
matti.hillbom@oulu.fi
First Name & Middle Initial & Last Name & Degree
Juha T Huhtakangas, MD
Phone
358-8-315-4032
Email
juha.huhtakangas@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Tarja H Haapaniemi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Sami T Tetri, MD
First Name & Middle Initial & Last Name & Degree
Michaela Bode, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pertti Saloheimo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Eeva-Riitta Savolainen, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
16926557
Citation
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. Erratum In: Cerebrovasc Dis. 2006;22(5-6):461. Katse, Markku [corrected to Kaste, Markku].
Results Reference
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PubMed Identifier
17478736
Citation
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.
Results Reference
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Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

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