An observational study in Subarachnoid Hemorrhage, Aneurysmal and Poor Grade Subarachnoid Hemorrhage, sponsored by IRCCS San Raffaele. Recruiting at 10 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by IRCCS San Raffaele · Observational
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:
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's planned enrollment of 800 is above the median of 117 across 226 observational studies indexed under Subarachnoid Hemorrhage.
Browse Subarachnoid Hemorrhage studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification
Exclusion Criteria:
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
Standard management according to international/national guidelines. Observational study
Clinical Outcome
modified Rankin Scale
Time frame: 6 months.
Clinical Outcome
modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.
Time frame: 12 months
Long-Term clinical outcome
modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead)
Time frame: 12-60 months
Delayed Cerebral Ischemia
Delayed Cerebral Ischemia
Time frame: onset-30 days
Rebleeding
Rebleeding
Time frame: onset-48hours
Treatment Complications
Treatment Complications
Time frame: onset-1 week
Decompressive Craniotomy
Incidence, strategy (primary or secondary), predictors and clinical impact
Time frame: onset-3 weeks
Ventriculo-peritoneal shunt
Incidence, strategy (primary or secondary), predictors and clinical impact
Time frame: onset-4 weeks
CSF drainage
Use of external ventricular drainage or lumbar drainage according to institutional protocol. Clinical impact.
Time frame: onset-3 weeks
Volumetric analysis of intracranial bleeding
Volumetric analysis and distribution assessment of intracranial bleeding. Clinical impact
Time frame: onset-24hours
Volumetric analysis of delayed cerebral ischemia
Volumetric analysis and location assessment of delayed cerebral ischemia. Clinical impact
Time frame: onset-3 weeks
Plan to share: Undecided
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IRCCS San Raffaele