Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00699465
• Other study ID #: EUDRACT 2007-006206-24
• Status: Recruiting
• Phase: Phase 4
• First received: June 12, 2008
• Last updated: July 1, 2010
• Start date: August 2008
• Est. completion date: December 2013

Study information

• Verified date: July 2010
• Source: University of Oulu
• Contact: Matti E Hillbom, MD, PhD
• Phone: 358-8-315-4518
• Email: matti.hillbom[@]oulu.fi
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Thromboembolism
• Venous Thromboembolism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Finland	Department of Neurology, Oulu University Hospital	Oulu

Sponsors (2)

Lead Sponsor	Collaborator
University of Oulu	Helsinki University

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. Epub 2007 May 3. — View 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. Epub 2006 Jul 28. Erratum in: Cerebrovasc Dis. 2006;22(5-6):461. Katse, Markku [corrected to Kaste, Markku]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bleeding complications including rebleedings occurring within the treatment period		90 days	Yes
Secondary	Increase in ICH volume observed by head CT or at autopsy during the treatment period		90 days	Yes
Secondary	Cardiovascular death occurring within the treatment period		90 days	Yes
Secondary	Death due to any cause occurring within the treatment period		90 days	Yes