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Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04945603
Acronym
POGASH
Enrollment
800
Registered
2021-06-30
Start date
2021-05-25
Completion date
2028-12-31
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poor Grade Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal

Brief summary

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: 1. outcome predictors in the emergency department (so called early brain injury phase). 2. outcome predictors in the neurocritical care unit (so called delayed brain injury phase). 3. 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).

Interventions

OTHERStandard management according to international/national guidelines

Standard management according to international/national guidelines. Observational study

Sponsors

Azienda Ospedaliera Universitaria Integrata Verona
CollaboratorOTHER
Azienda Ospedaliero-Universitaria di Parma
CollaboratorOTHER
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
CollaboratorOTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
CollaboratorOTHER
A.O. Ospedale Papa Giovanni XXIII
CollaboratorOTHER
ASL Taranto
CollaboratorOTHER
Ospedale V. Fazzi
CollaboratorOTHER
IRCCS Istituto delle Scienze Neurologiche di Bologna
CollaboratorOTHER
Azienda Ospedaliero Universitaria Maggiore della Carita
CollaboratorOTHER
IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical Outcome6 months.modified Rankin Scale

Secondary

MeasureTime frameDescription
Delayed Cerebral Ischemiaonset-30 daysDelayed Cerebral Ischemia
Rebleedingonset-48hoursRebleeding
Treatment Complicationsonset-1 weekTreatment Complications
Decompressive Craniotomyonset-3 weeksIncidence, strategy (primary or secondary), predictors and clinical impact
Long-Term clinical outcome12-60 monthsmodified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead)
CSF drainageonset-3 weeksUse of external ventricular drainage or lumbar drainage according to institutional protocol. Clinical impact.
Volumetric analysis of intracranial bleedingonset-24hoursVolumetric analysis and distribution assessment of intracranial bleeding. Clinical impact
Volumetric analysis of delayed cerebral ischemiaonset-3 weeksVolumetric analysis and location assessment of delayed cerebral ischemia. Clinical impact
Ventriculo-peritoneal shuntonset-4 weeksIncidence, strategy (primary or secondary), predictors and clinical impact

Countries

Italy

Contacts

Primary ContactPietro Panni, P.I., M.D.
panni.pietro@hsr.it+393406311389
Backup ContactAndrea Falini, Professor of Neuroradiology
falini.andrea@hsr.it+39 0226432239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026