Document Detail


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.
MedLine Citation:
PMID:  20798370     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
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:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2010-08-26
Journal Detail:
Title:  Stroke; a journal of cerebral circulation     Volume:  41     ISSN:  1524-4628     ISO Abbreviation:  Stroke     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-29     Completed Date:  2010-10-19     Revised Date:  2014-02-19    
Medline Journal Info:
Nlm Unique ID:  0235266     Medline TA:  Stroke     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2391-5     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Brain Ischemia / etiology*,  radiography
Clinical Trials as Topic
Humans
Outcome Assessment (Health Care)
Subarachnoid Hemorrhage / complications*,  radiography
Treatment Outcome
Grant Support
ID/Acronym/Agency:
G0501444//Medical Research Council; 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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