162 Center-Effect in Patient Outcome After Enrollment Into Randomized Clinical Trials in Aneurysmal Subarachnoid Hemorrhage

Neurosurgery ◽  
2015 ◽  
Vol 62 ◽  
pp. 219
Author(s):  
Blessing N.R. Jaja ◽  
Tom Schweizer ◽  
R. Loch Macdonald
Keyword(s):  
Patient Outcome ◽  
Clinical Trials ◽  
Subarachnoid Hemorrhage ◽  
Randomized Clinical Trials ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Center Effect

scholarly journals Medical Management of Cerebral Vasospasm following Aneurysmal Subarachnoid Hemorrhage: A Review of Current and Emerging Therapeutic Interventions

2013 ◽  
Vol 2013 ◽  
pp. 1-10 ◽  
Author(s):  
Peter Adamczyk ◽  
Shuhan He ◽  
Arun Paul Amar ◽  
William J. Mack
Keyword(s):  
Clinical Trials ◽  
Subarachnoid Hemorrhage ◽  
Cerebral Vasospasm ◽  
Medical Management ◽  
Management Practices ◽  
Randomized Clinical Trials ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Therapeutic Interventions ◽  
Free Radical Scavengers ◽  
Therapeutic Modalities

Cerebral vasospasm is a major source of morbidity and mortality in patients with aneurysmal subarachnoid hemorrhage (aSAH). Evidence suggests a multifactorial etiology and this concept remains supported by the assortment of therapeutic modalities under investigation. The authors provide an updated review of the literature for previous and recent clinical trials evaluating medical treatments in patients with cerebral vasospasm secondary to aSAH. Currently, the strongest evidence supports use of prophylactic oral nimodipine and initiation of triple-H therapy for patients in cerebral vasospasm. Other agents presented in this report include magnesium, statins, endothelin receptor antagonists, nitric oxide promoters, free radical scavengers, thromboxane inhibitors, thrombolysis, anti-inflammatory agents and neuroprotectants. Although promising data is beginning to emerge for several treatments, few prospective randomized clinical trials are presently available. Additionally, future investigational efforts will need to resolve discrepant definitions and outcome measures for cerebral vasospasm in order to permit adequate study comparisons. Until then, definitive recommendations cannot be made regarding the safety and efficacy for each of these therapeutic strategies and medical management practices will continue to be implemented in a wide-ranging manner.

scholarly journals Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Roland Roelz ◽  
Fabian Schubach ◽  
Volker A. Coenen ◽  
Carolin Jenkner ◽  
Christian Scheiwe ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Subarachnoid Hemorrhage ◽  
Brain Injury ◽  
Neurological Outcome ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Standard Of Care ◽  
Secondary Brain Injury ◽  
Ringer’S Solution ◽  
Randomized Controlled ◽  
Therapy Protocol

Abstract Background Delayed cerebral infarction (DCI) is a major cause of death and poor neurological outcome in patients with aneurysmal subarachnoid hemorrhage (aSAH). Direct intrathecal therapies with fibrinolytic and spasmolytic drugs have appeared promising in clinical trials. However, access to the subarachnoid space for intrathecal drug administration is an unsolved problem so far, especially in patients with endovascular aneurysm securing. We investigate a therapy protocol based on stereotactic catheter ventriculocisternostomy (STX-VCS), a new approach to overcome this problem. The primary objective of this study is to assess whether cisternal lavage with urokinase, nimodipine, and Ringer’s solution administered via a stereotactically implanted catheter into the basal cisterns (= investigational treatment (IT)) is safe and improves neurological outcome in patients with aSAH. Methods This is a randomized, controlled, parallel-group, open-label phase II trial. Fifty-four patients with severe aSAH (WFNS grade ≥ 3) will be enrolled at one academic tertiary care center in Southern Germany. Patients will be randomized at a ratio of 1:1 to receive either standard of care only or standard of care plus the IT. The primary endpoint is the proportion of subjects with a favorable outcome on the Modified Rankin Scale (defined as mRS 0–3) at 6 months after aSAH. Further clinical and surrogate outcome parameters are defined as secondary endpoints. Discussion New approaches for the prevention and therapy of secondary brain injury in patients with aSAH are urgently needed. We propose this RCT to assess the clinical safety and efficacy of a novel therapy protocol for intrathecal administration of urokinase, nimodipine, and Ringer’s solution. Trial registration Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00015645. Registered on 8 May 2019

Abstract WP386: Acute Catecholamine Surge in Patients with Aneurysmal Subarachnoid Hemorrhage: Characteristics and Prognostic Value

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Koichi Uramaru ◽  
Yuichiro Kikkawa ◽  
Hiroki Sato ◽  
Taro Yanagawa ◽  
Kaima Suzuki ◽  
...  
Keyword(s):  
Patient Outcome ◽  
Subarachnoid Hemorrhage ◽  
Acute Phase ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Demographic Data ◽  
Plasma Concentrations ◽  
Clinical Grade ◽  
High Concentration ◽  
Mutual Correlation ◽  
Inflammatory Reactions

Objectives: The characteristics of serum catecholamine concentration at the hyper-acute phase of aneurysmal subarachnoid hemorrhage (SAH) and its relationship between patient outcome and delayed vasospasm were investigated. Methods: Patients with aneurysmal SAH (170) were prospectively studied between August 2008 and June 2011. Baseline demographic data and physiological parameters, including plasma concentrations of adrenaline (AD), noradrenaline (NA) and dopamine (DP) were evaluated for all patients. Results: On admission, plasma AD, NA and DP levels were significantly higher in patients with a poor clinical grade on admission (Hunt & Kosnik: IV-V), compared to those with a good clinical grade on admission (Hunt & Kosnik: I-III). AD showed a markedly high concentration immediately after the onset of SAH and then rapidly decreased. NA levels peaked within 6 hours after onset, then significantly decreased. The increase of DP with time was not significant, but showed a similar trend to that of NA. The level of each catecholamine showed significant mutual correlation. Multivariate analyses demonstrated age, poor clinical grade, plasma AD and NA levels were predictors of poor patient outcome, and.poor clinical grade, Fisher scale and plasma AD level were predictors of the development of delayed vasospasm. Conclusions: The present findings suggest that sympathetic activation in patients in the acute phase of SAH reflects the severity of SAH, and is closely related to the development of delayed vasospasm, leading to the subsequent immune response and inflammatory reactions. Strategies for suppressing catecholamine at the hyperacute phase may contribute to vasospasm prevention and improve patient outcome.

scholarly journals Microvascular platelet aggregation and thrombosis after subarachnoid hemorrhage: A review and synthesis

2020 ◽  
Vol 40 (8) ◽  
pp. 1565-1575 ◽  
Author(s):  
Julian V Clarke ◽  
Julia M Suggs ◽  
Deepti Diwan ◽  
Jin V Lee ◽  
Kim Lipsey ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Subarachnoid Hemorrhage ◽  
Platelet Aggregation ◽  
Randomized Clinical Trials ◽  
Experimental Studies ◽  
Delayed Cerebral Ischemia ◽  
Therapeutic Options ◽  
Large Artery ◽  
Ongoing Research ◽  
Human Autopsy

Delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage (SAH) has been associated with numerous pathophysiological sequelae, including large artery vasospasm and microvascular thrombosis. The focus of this review is to provide an overview of experimental animal model studies and human autopsy studies that explore the temporal-spatial characterization and mechanism of microvascular platelet aggregation and thrombosis following SAH, as well as to critically assess experimental studies and clinical trials highlighting preventative therapeutic options against this highly morbid pathophysiological process. Upon review of the literature, we discovered that microvascular platelet aggregation and thrombosis occur after experimental SAH across multiple species and SAH induction techniques in a similar time frame to other components of DCI, occurring in the cerebral cortex and hippocampus across both hemispheres. We discuss the relationship of these findings to human autopsy studies. In the final section of this review, we highlight the important therapeutic options for targeting microvascular platelet aggregation and thrombosis, and emphasize why therapeutic targeting of this neurovascular pathology may improve patient care. We encourage ongoing research into the pathophysiology of SAH and DCI, especially in regard to microvascular platelet aggregation and thrombosis and the translation to randomized clinical trials.

scholarly journals Lessons from the CONSCIOUS-1 Study

2020 ◽  
Vol 9 (9) ◽  
pp. 2970 ◽  
Author(s):  
Alexander J. Schupper ◽  
Matthew E. Eagles ◽  
Sean N. Neifert ◽  
J Mocco ◽  
R. Loch Macdonald
Keyword(s):  
Subarachnoid Hemorrhage ◽  
Randomized Clinical Trials ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Phase 2 ◽  
Phase 2 Trial ◽  
Angiographic Vasospasm ◽  
Improved Outcomes ◽  
Trial Testing ◽  
Endpoint Data ◽  
Post Hoc

After years of research on treatment of aneurysmal subarachnoid hemorrhage (aSAH), including randomized clinical trials, few treatments have been shown to be efficacious. Nevertheless, reductions in morbidity and mortality have occurred over the last decades. Reasons for the improved outcomes remain unclear. One randomized clinical trial that has been examined in detail with these questions in mind is Clazosentan to Overcome Neurological Ischemia and Infarction Occurring After Subarachnoid Hemorrhage (CONSCIOUS-1). This was a phase-2 trial testing the effect of clazosentan on angiographic vasospasm (aVSP) in patients with aSAH. Clazosentan decreased moderate to severe aVSP. There was no statistically significant effect on the extended Glasgow outcome score (GOS), although the study was not powered for this endpoint. Data from the approximately 400 patients in the study were detailed, rigorously collected and documented and were generously made available to one investigator. Post-hoc analyses were conducted which have expanded our knowledge of the management of aSAH. We review those analyses here.

scholarly journals Evidence favoring the efficacy of convalescent plasma for COVID-19 therapy

2020 ◽  
Author(s):  
Stephen A. Klassen ◽  
Jonathon W. Senefeld ◽  
Patrick W. Johnson ◽  
Rickey E. Carter ◽  
Chad C. Wiggins ◽  
...  
Keyword(s):  
Patient Outcome ◽  
Clinical Trials ◽  
Case Report ◽  
Mortality Rate ◽  
Therapeutic Agent ◽  
Randomized Clinical Trials ◽  
Matched Control ◽  
Case Series ◽  
Outcome Data ◽  
Control Case

AbstractTo determine the effect of COVID-19 convalescent plasma on mortality, we aggregated patient outcome data from randomized clinical trials (RCT), matched-control, case series, and case report studies. Random-effects analyses of RCT data demonstrated that hospitalized COVID-19 patients transfused with convalescent plasma exhibited a lower mortality rate compared to patients receiving standard treatments. These data provide evidence favoring the efficacy of human convalescent plasma as a therapeutic agent in hospitalized COVID-19 patients.

scholarly journals Dynamic Pattern of Interleukin-1beta and -10 in Cerebrospinal Fluid following Aneurysmal Subarachnoid Hemorrhage

2014 ◽  
Vol 6 (2) ◽  
pp. 97
Author(s):  
Yesaya Yunus ◽  
Julius July ◽  
Andi Asadul Islam ◽  
Eka Julianta Wahjoepramono ◽  
Irawan Yusuf
Keyword(s):  
Patient Outcome ◽  
Cerebrospinal Fluid ◽  
Subarachnoid Hemorrhage ◽  
Inflammatory Cytokine ◽  
Prospective Observational Study ◽  
Aneurysmal Subarachnoid Hemorrhage ◽  
Neurological Deficits ◽  
Enzyme Linked Immunosorbent Assay ◽  
Wilcoxon Rank Sum Test ◽  
Anti Inflammatory Cytokine

BACKGROUND: Inflammation following aneurysmal subarachnoid hemorrhage (SAH) is associated with patient outcome. This study aimed to analyze the dynamics pattern of the pro-inflammatory interleukin (IL)-1β and anti-inflammatory cytokine IL-10 in the cerebrospinal fluid (CSF) following aneurysmal SAH.METHODS: This is a prospective observational study. The CSF was collected prior to surgery, and on the 2nd, 4th and 6th days after surgery. The CSF was then analyzed for IL-1β and -10 using enzyme-linked immunosorbent assay. Delayed Ischemic Neurological Deficits (DIND) was determined based on new neurological deficits within the first week after surgery. Data was analysed with T test or Wilcoxon Rank-Sum test to evaluate the pattern of biomarkers between DIND and non-DIND groups.RESULTS: There were 33 patients enrolled in this study, 16 patients (48.48%) who experienced DIND and 17 patients (51.52%) were non-DIND. There were significant increase dynamic levels of IL-10 and -1β in DIND patients (p<0.05).CONCLUSION: Significant increase levels of IL-10 and -1β in CSF after aneurysmal SAH are associated with DIND.KEYWORDS: IL-1β, IL-10, DIND

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