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

• Published in: Stroke (1970) Vol. 41; no. 10; pp. 2391 - 2395
• Main Authors: VERGOUWEN, Mervyn D. I, VERMEULEN, Marinus, LOCH MACDONALD, R, DIRINGER, Michael N, BRODERICK, Joseph P, DREIER, Jens P, ROOS, Yvo B. W. E. M, VAN GIJN, Jan, RINKEL, Gabriel J. E, WIJDICKS, Eelco F, MUIZELAAR, J. Paul, MENDELOW, A. David, JUVELA, Seppo, YONAS, Howard, TERBRUGGE, Karel G
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 01.10.2010
• Subjects: Biological and medical sciences; Brain Ischemia - diagnostic imaging; Brain Ischemia - etiology; Clinical Trials as Topic; Humans; Medical sciences; Neurology; Neuropharmacology; Neuroprotective agent; Outcome Assessment (Health Care); Pharmacology. Drug treatments; Radiography; Subarachnoid Hemorrhage - complications; Subarachnoid Hemorrhage - diagnostic imaging; Treatment Outcome; Vascular diseases and vascular malformations of the nervous system; Cerebral infarction; Stroke; Nervous system diseases; Prognosis; Subarachnoid hemorrhage; Vasoconstriction; Cardiovascular disease; delayed cerebral ischemia; Cerebral disorder; Vascular disease; Cerebral hemorrhage; Central nervous system disease; Brain ischemia; Vasospasm; definition; Cerebrovascular disease
• ISSN: 0039-2499; 1524-4628
• DOI: 10.1161/STROKEAHA.110.589275

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. 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. 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. 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.