Clinical trial NCT00699465: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intracerebral Hemorrhage
Keywords: Thromboprophylaxis
Prevention of venous thromboembolism after ICH
Enoxaparin
Intermittent pneumatic compression
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2008-06-18
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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.
timeFrame: 90 days
Secondary outcomes:
measure: Bleeding complications including rebleedings occurring within the treatment period
timeFrame: 90 days
measure: Increase in ICH volume observed by head CT or at autopsy during the treatment period
timeFrame: 90 days
measure: Cardiovascular death occurring within the treatment period
timeFrame: 90 days
measure: Death due to any cause occurring within the treatment period
timeFrame: 90 days
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Neurology, Oulu University Hospital
Study officials:
affiliation: Oulu University Central Hospital, Department of Neurology
name: Matti E Hillbom, MD, PhD
role: STUDY_CHAIR
affiliation: Turku University Central Hospital, Department of Neurosurgery
name: Seppo S Juvela, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki University Central Hospital, Department of Neurology
name: Turgut Tatlisumak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Päijät-Häme Central Hospital, Department of Neurology
name: Liisa K Luostarinen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keski-Suomen Keskussairaala
name: Aimo Rissanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tampere University Hospital
name: Heikki Numminen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.