Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oulu
• Collaborators: Helsinki University; University of Helsinki
• Treatments: Enoxaparin; Enoxaparin sodium

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