Randomized, double-blind, placebo-controlled, pilot trial of high-dose methylprednisolone in aneurysmal subarachnoid hemorrhage

Gomis, Philippe; Graftieaux, Jean Pierre; Sercombe, Richard; Hettler, D.; Scherpereel, B; Rousseaux, P

doi:10.3171/2009.4.jns081377

Cited by 95 publications

(76 citation statements)

References 30 publications

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“…Because of its delayed onset, this complication is often called delayed cerebral ischemia (DCI). 2,4 Besides the term "DCI," many other terms are used in the literature to describe this clinical phenomenon, such as delayed ischemic neurological deficit, [5][6][7] delayed ischemic deficit, 8,9 delayed neurological deficit, 10,11 secondary cerebral ischemia, 12,13 vasospasm, 14,15 clinical vasospasm, 16,17 symptomatic vasospasm, 18,19 symptomatic ischemia, 20 and cerebral infarction. 21 The use of so many different terms is problematic, not only because many studies provide incomplete definitions of the terms used, if at all, 22,23 but also because a variety of definitions are used for the same term.…”

mentioning

confidence: 99%

Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies

Vergouwen

Vermeulen

Gijn

et al. 2010

Stroke

1,304

938

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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)

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mentioning

confidence: 99%

Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies

Vergouwen

Vermeulen

Gijn

et al. 2010

Stroke

1,304

938

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“…The remaining 24 trials were included in the analysis, including 8,552 patients (Macdonald et al, 2008;Asano et al, 1996;Chou et al, 2008;Gomis et al, 2010;Haley et al, 1993Haley et al, , 1997Hop et al, 2000;Kassell et al, 1996;Ohman and Heiskanen, 1988;Petruk et al, 1988;Pickard et al, 1989;Saito et al, 1998;Shaw et al, 2000;Shibuya et al, 1992;Siironen et al, 2003;Juvela et al, 2005;Springborg et al, 2007;Suzuki et al, 1989;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Westermaier et al, 2010;Wong et al, 2010Wong et al, , 2011. A total of 4,818 patients were randomized to pharmaceutical treatment, and 3,734 patients to placebo.…”

Section: Resultsmentioning

confidence: 99%

“…For blinding, risk of bias was low in 20 studies (Macdonald et al, 2008;Asano et al, 1996;Gomis et al, 2010;Haley et al, 1993Haley et al, , 1997Hop et al, 2000;Kassell et al, 1996;Petruk et al, 1988;Pickard et al, 1989;Shaw et al, 2000;Shibuya et al, 1992;Siironen et al, 2003;Springborg et al, 2007;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Westermaier et al, 2010;Wong et al, 2010), and unclear in four studies (Chou et al, 2008;Ohman and Heiskanen, 1988;Saito et al, 1998;Suzuki et al, 1989). High risk of bias was not observed in any of the studies.…”

Section: Risk Of Bias Assessmentsmentioning

confidence: 95%

“…For allocation concealment, risk of bias was low in 13 (Macdonald et al, 2008;Asano et al, 1996;Haley et al, 1993;Hop et al, 2000;Petruk et al, 1988;Pickard et al, 1989;Shaw et al, 2000;Shibuya et al, 1992;Springborg et al, 2007;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Wong et al, 2010) and unclear in 11 studies (Chou et al, 2008;Gomis et al, 2010;Haley et al, 1997;Kassell et al, 1996;Ohman and Heiskanen, 1988;Saito et al, 1998;Siironen et al, 2003;Suzuki et al, 1989;Westermaier et al, 2010) ( Table 1). For blinding, risk of bias was low in 20 studies (Macdonald et al, 2008;Asano et al, 1996;Gomis et al, 2010;Haley et al, 1993Haley et al, , 1997Hop et al, 2000;Kassell et al, 1996;Petruk et al, 1988;Pickard et al, 1989;Shaw et al, 2000;Shibuya et al, 1992;Siironen et al, 2003;Springborg et al, 2007;Tseng et al, 2009;van den Bergh et al, 2005van den Bergh et al, , 2006Westermaier et al, 2010;…”

Section: Risk Of Bias Assessmentsmentioning

confidence: 99%

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Lower incidence of cerebral infarction correlates with improved functional outcome after aneurysmal subarachnoid hemorrhage

Vergouwen

Etminan

Ilodigwe

et al. 2011

J Cereb Blood Flow Metab

128

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Despite an undisputed association between vasospasm and delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage (SAH), there is debate if this association implies causality. It has been suggested that cerebral infarction is a better outcome measure than vasospasm in clinical trials and observational studies. To further investigate the relationship between infarction and outcome, we performed a systematic review and meta-analysis of all randomized, double-blind, placebo-controlled trials that studied the efficacy of pharmaceutical preventive strategies in SAH patients, and had both cerebral infarction and clinical outcome as outcome events. Effect sizes were expressed in (pooled) risk ratio (RR) estimates with corresponding 95% confidence intervals (CIs). Sensitivity analyses were performed for studies with a low risk of bias and for those who reported outcome at 3 months after SAH. Twenty-four studies including 8,552 patients were included. Pharmaceutical treatments decreased the incidence of both cerebral infarction (RR: 0.83; 95% CI: 0.74 to 0.93) and of poor functional outcome (RR: 0.92; 95% CI: 0.86 to 0.98). The sensitivity analyses did not change the results essentially. These data suggest that the previously observed association between cerebral infarction and functional outcome implies causality, and that cerebral infarction is a better outcome measure than vasospasm in clinical trials and observational studies.

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“…Studies of tirilazad, a chemical compound structurally resembling a steroid but without glucocorticoid, mineralocorticoid, or other hormonal effects, were excluded; its effects have been summarized in a meta-analysis [21] . Seven final articles were included in the meta-analyses [22][23][24][25][26][27][28] .…”

Section: Search Strategy and Selection Criteriamentioning

confidence: 99%

Corticosteroids in the Management of Hyponatremia, Hypovolemia, and Vasospasm in Subarachnoid Hemorrhage: A Meta-Analysis

Mistry

Mistry²,

Kumar³

et al. 2016

Cerebrovasc Dis

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Background: Cerebral vasospasm and sodium and fluid imbalances are common sequelae of aneurysmal subarachnoid hemorrhage (SAH) and cause of significant morbidity and mortality. Studies have shown the benefit of corticosteroids in the management of these sequelae. We have reviewed the literature and analyzed the available data for corticosteroid use after SAH. Methods: PubMed, EMBASE, and Cochrane electronic databases were searched without language restrictions, and 7 observational, controlled clinical studies of the effect of corticosteroids in the management of SAH patients were identified. Data on sodium and fluid balances, symptomatic vasospasm (SVS), and outcomes were pooled for meta-analyses using the Mantel-Haenszel random effects model. Results: Corticosteroids, specifically hydrocortisone and fludrocortisone, decreased natriuretic diuresis and incidence of hypovolemia. Corticosteroid administration is associated with lower incidence of SVS in the absence of nimodipine, but does not alter the neurological outcome. Conclusions: Supplementation of corticosteroids with mineralocorticoid activity, such as hydrocortisone or fludrocortisone, helps in maintaining sodium and volume homeostasis in SAH patients. Larger trials are warranted to confirm the effects of corticosteroids on SVS and patient outcomes.

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Randomized, double-blind, placebo-controlled, pilot trial of high-dose methylprednisolone in aneurysmal subarachnoid hemorrhage

Abstract: A safe and simple treatment with methylprednisolone did not reduce the incidence of symptomatic vasospasm but improved ability and functional outcome at 1 year after SAH.

Cited by 95 publications

References 30 publications

Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies

Definition of Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage as an Outcome Event in Clinical Trials and Observational Studies

Lower incidence of cerebral infarction correlates with improved functional outcome after aneurysmal subarachnoid hemorrhage

Corticosteroids in the Management of Hyponatremia, Hypovolemia, and Vasospasm in Subarachnoid Hemorrhage: A Meta-Analysis

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