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.

Abstract:

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.

journal_name

Stroke

journal_title

Stroke

authors

Vergouwen MD,Vermeulen M,van Gijn J,Rinkel GJ,Wijdicks EF,Muizelaar JP,Mendelow AD,Juvela S,Yonas H,Terbrugge KG,Macdonald RL,Diringer MN,Broderick JP,Dreier JP,Roos YB

doi

10.1161/STROKEAHA.110.589275

subject

Has Abstract

pub_date

2010-10-01 00:00:00

pages

2391-5

issue

10

eissn

0039-2499

issn

1524-4628

pii

STROKEAHA.110.589275

journal_volume

41

pub_type

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