| Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. | |
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MedLine Citation:
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PMID: 20798370 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND AND PURPOSE: In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. METHODS: An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. RESULTS: It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. CONCLUSIONS: The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies. |
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Authors:
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Mervyn D I Vergouwen; Marinus Vermeulen; Jan van Gijn; Gabriel J E Rinkel; Eelco F Wijdicks; J Paul Muizelaar; A David Mendelow; Seppo Juvela; Howard Yonas; Karel G Terbrugge; R Loch Macdonald; Michael N Diringer; Joseph P Broderick; Jens P Dreier; Yvo B W E M Roos |
Publication Detail:
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Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2010-08-26 |
Journal Detail:
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Title: Stroke; a journal of cerebral circulation Volume: 41 ISSN: 1524-4628 ISO Abbreviation: Stroke Publication Date: 2010 Oct |
Date Detail:
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Created Date: 2010-09-29 Completed Date: 2010-10-19 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0235266 Medline TA: Stroke Country: United States |
Other Details:
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Languages: eng Pagination: 2391-5 Citation Subset: IM |
Affiliation:
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Department of Neurology, Academic Medical Center, Amsterdam, the Netherlands. m.d.vergouwen@amc.uva.nl |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Brain Ischemia
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etiology*,
radiography Clinical Trials as Topic Humans Outcome Assessment (Health Care) Subarachnoid Hemorrhage / complications*, radiography Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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P50 NS05597701A2/NS/NINDS NIH HHS; P50NS035966/NS/NINDS NIH HHS |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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