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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Early enoxaparin |
|
| 2 | Placebo Comparator | Late enoxaparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enoxaparin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding complications including rebleedings occurring within the treatment period | 90 days | |
| Increase in ICH volume observed by head CT or at autopsy during the treatment period | 90 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matti E Hillbom, MD, PhD | Contact | 358-8-315-4518 | matti.hillbom@oulu.fi | |
| Juha T Huhtakangas, MD | Contact | 358-8-315-4032 | juha.huhtakangas@ppshp.fi |
| Name | Affiliation | Role |
|---|---|---|
| Matti E Hillbom, MD, PhD | Oulu University Central Hospital, Department of Neurology | Study Chair |
| Seppo S Juvela, MD, PhD | Turku University Central Hospital, Department of Neurosurgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Oulu University Hospital | Recruiting | Oulu | 90029 OYS | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16926557 | 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. | |
| 17478736 |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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|
| enoxaparin placebo | Drug | 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. |
|
|
| Cardiovascular death occurring within the treatment period |
| 90 days |
| Death due to any cause occurring within the treatment period | 90 days |
| Turgut Tatlisumak, MD, PhD | Helsinki University Central Hospital, Department of Neurology | Principal Investigator |
| Liisa K Luostarinen, MD, PhD | Päijät-Häme Central Hospital, Department of Neurology | Principal Investigator |
| Aimo Rissanen, MD, PhD | Keski-Suomen Keskussairaala | Principal Investigator |
| Heikki Numminen, MD, PhD | Tampere University Hospital | Principal Investigator |
| 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |