drugset / Trial / NCT00699465
Prevention of Venous Thromboembolism in Patients With Acute Primary Intracerebral Hemorrhage
RandomizedParallel-groupDouble-blindPrevention
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.
Timeline
- Start
- 2008-08
- Primary completion
- 2013-07
- Completion
- 2013-12
Publications
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Enoxaparin sodium | Other / unclassified | 20 mg | Subcutaneous |