Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

Study Overview
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Brief Summary
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Multicentric registry study in order to define outcome, predictors, treatment effects and their modifiers in poor grade aneurysmal subarachnoid haemorrhage patients. The search for outcome predictors is going to be subdivided into three main research areas: outcome predictors in the emergency department (so called early brain injury phase). outcome predictors in the neurocritical care unit (so called delayed brain injury phase). Treatment strategies. Two other areas of research are identified: delayed cerebral ischemia (incidence, treatment, predictors, impact on outcome) and long term follow-up (recent evidences suggest that there may be a non-negligible proportion of poor grade subarachnoid hemorrhage patients who may benefit from substantial improvement at long-term (after 6-12 months of follow-up).

Official Title
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Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group

Conditions
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Subarachnoid Hemorrhage, Aneurysmal, Poor Grade Subarachnoid Hemorrhage

Intervention / Treatment
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* Other: Standard management according to international/national guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification. Exclusion Criteria: Patients younger than 18 years old. Pregnant or breast-feeding patients. Aneurysmal subarachnoid hemorrhage due to trauma or vascular malformations other than cerebral aneurysms.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Poor Grade Subarachnoid Hemorrhage<br>All patients (prospective and retrospective) included will have to present a subarachnoid hemorrhage defined poor grade according to the WFNS scale due to the rupture of an intracranial aneurysm. The patients are managed according to both most recent international guidelines on the specific disease (Stroke, May 2012) and according to national and institutional guidelines/protocols. | Other: Standard management according to international/national guidelines<br>* Standard management according to international/national guidelines. Observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome | modified Rankin Scale | 6 months. | 
| Clinical Outcome | modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-Term clinical outcome | modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) | 12-60 months | 
| Delayed Cerebral Ischemia | Delayed Cerebral Ischemia | onset-30 days | 
| Rebleeding | Rebleeding | onset-48hours | 
| Treatment Complications | Treatment Complications | onset-1 week | 
| Decompressive Craniotomy | Incidence, strategy (primary or secondary), predictors and clinical impact | onset-3 weeks | 
| Ventriculo-peritoneal shunt | Incidence, strategy (primary or secondary), predictors and clinical impact | onset-4 weeks | 
| CSF drainage | Use of external ventricular drainage or lumbar drainage according to institutional protocol. Clinical impact. | onset-3 weeks | 
| Volumetric analysis of intracranial bleeding | Volumetric analysis and distribution assessment of intracranial bleeding. Clinical impact | onset-24hours | 
| Volumetric analysis of delayed cerebral ischemia | Volumetric analysis and location assessment of delayed cerebral ischemia. Clinical impact | onset-3 weeks |