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Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

This study is currently recruiting participants.
Verified July 2010 by University of Oulu
Sponsor:
Collaborator:
Helsinki University
Information provided by:
University of Oulu
ClinicalTrials.gov Identifier:
NCT00699465
First received: June 12, 2008
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  Purpose
  • 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.

Condition Intervention Phase
Intracerebral Hemorrhage
 Drug: enoxaparin
Drug: enoxaparin placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oulu:

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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bleeding complications including rebleedings occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Increase in ICH volume observed by head CT or at autopsy during the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Cardiovascular death occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Death due to any cause occurring within the treatment period [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 320
Study Start Date: August 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699465

Contacts
Contact: Matti E Hillbom, MD, PhD 358-8-315-4518 matti.hillbom@oulu.fi
Contact: Juha T Huhtakangas, MD 358-8-315-4032 juha.huhtakangas@ppshp.fi

Locations
Finland
Department of Neurology, Oulu University Hospital Recruiting
Oulu, Finland, 90029 OYS
Contact: Matti E Hillbom, professor     358-8-315-4518     matti.hillbom@oulu.fi    
Contact: Juha T Huhtakangas, MD     358-8-315-4032     juha.huhtakangas@ppshp.fi    
Sub-Investigator: Tarja H Haapaniemi, MD, PhD            
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            
Sponsors and Collaborators
University of Oulu
Helsinki University
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: 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 Central Hospital
  More Information

Publications:

Responsible Party: Oulu University Hospital (Matti Hillbom), Oulu University Hospital
ClinicalTrials.gov Identifier: NCT00699465     History of Changes
Other Study ID Numbers: EUDRACT 2007-006206-24
Study First Received: June 12, 2008
Last Updated: July 1, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
Thromboprophylaxis
Prevention of venous thromboembolism after ICH
Enoxaparin
Intermittent pneumatic compression

Additional relevant MeSH terms:
Hemorrhage
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cerebral Hemorrhage
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 June 17, 2013