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.

Mervyn D I Vergouwen, Marinus Vermeulen, Jan van Gijn, Gabriel J E Rinkel, Eelco F. Wijdicks, Jan 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

Research output: Contribution to journalArticle

495 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)2391-2395
Number of pages5
JournalStroke; a journal of cerebral circulation
Volume41
Issue number10
DOIs
StatePublished - Oct 2010

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Subarachnoid Hemorrhage
Brain Ischemia
Observational Studies
Clinical Trials
Research
Outcome Assessment (Health Care)
Clinical Studies
Cerebral Infarction
Infarction
Autopsy
Angiography

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. / Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F.; Muizelaar, Jan Paul; Mendelow, A. David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G.; Macdonald, R. Loch; Diringer, Michael N.; Broderick, Joseph P.; Dreier, Jens P.; Roos, Yvo B W E M.

In: Stroke; a journal of cerebral circulation, Vol. 41, No. 10, 10.2010, p. 2391-2395.

Research output: Contribution to journalArticle

Vergouwen, MDI, Vermeulen, M, van Gijn, J, Rinkel, GJE, Wijdicks, EF, Muizelaar, JP, Mendelow, AD, Juvela, S, Yonas, H, Terbrugge, KG, Macdonald, RL, Diringer, MN, Broderick, JP, Dreier, JP & Roos, YBWEM 2010, '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.', Stroke; a journal of cerebral circulation, vol. 41, no. 10, pp. 2391-2395. https://doi.org/10.1161/STROKEAHA.110.589275
Vergouwen, Mervyn D I ; Vermeulen, Marinus ; van Gijn, Jan ; Rinkel, Gabriel J E ; Wijdicks, Eelco F. ; Muizelaar, Jan Paul ; Mendelow, A. David ; Juvela, Seppo ; Yonas, Howard ; Terbrugge, Karel G. ; Macdonald, R. Loch ; Diringer, Michael N. ; Broderick, Joseph P. ; Dreier, Jens P. ; Roos, Yvo B W E M. / 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. In: Stroke; a journal of cerebral circulation. 2010 ; Vol. 41, No. 10. pp. 2391-2395.
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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.",
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T1 - Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies

T2 - proposal of a multidisciplinary research group.

AU - Vergouwen, Mervyn D I

AU - Vermeulen, Marinus

AU - van Gijn, Jan

AU - Rinkel, Gabriel J E

AU - Wijdicks, Eelco F.

AU - Muizelaar, Jan Paul

AU - Mendelow, A. David

AU - Juvela, Seppo

AU - Yonas, Howard

AU - Terbrugge, Karel G.

AU - Macdonald, R. Loch

AU - Diringer, Michael N.

AU - Broderick, Joseph P.

AU - Dreier, Jens P.

AU - Roos, Yvo B W E M

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N2 - 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.

AB - 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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