Overview

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