Clinical trial NCT04945603: Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
Official title: Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Poor Grade Subarachnoid Hemorrhage
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Integrata Verona
name: Azienda Ospedaliero-Universitaria di Parma
name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: A.O. Ospedale Papa Giovanni XXIII
name: ASL Taranto
name: Ospedale V. Fazzi
name: IRCCS Istituto delle Scienze Neurologiche di Bologna
name: Azienda Ospedaliero Universitaria Maggiore della Carita
First posted: 2021-06-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Outcome
timeFrame: 6 months.
measure: Clinical Outcome
timeFrame: 12 months
Secondary outcomes:
measure: Long-Term clinical outcome
timeFrame: 12-60 months
measure: Delayed Cerebral Ischemia
timeFrame: onset-30 days
measure: Rebleeding
timeFrame: onset-48hours
measure: Treatment Complications
timeFrame: onset-1 week
measure: Decompressive Craniotomy
timeFrame: onset-3 weeks
measure: Ventriculo-peritoneal shunt
timeFrame: onset-4 weeks
measure: CSF drainage
timeFrame: onset-3 weeks
measure: Volumetric analysis of intracranial bleeding
timeFrame: onset-24hours
measure: Volumetric analysis of delayed cerebral ischemia
timeFrame: onset-3 weeks
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST Ospedale Papa Giovanni XXIII
city: Bologna
country: Italy
facility: IRCCS Bellaria
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Novara
country: Italy
facility: Ospedale Maggiore della Città di Novara
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Taranto
country: Italy
facility: Ospedale Santissima Annunziata
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata
Study officials:
affiliation: Department of Neuroradiology, Department of Neurosurgery
name: Pietro Panni, P.I., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Panni P, Ambrosi A; POGASH (Poor Grade Aneurysmal Subarachnoid Hemorrhage) Investigators. In Reply: Clinical Impact and Predictors of Aneurysmal Rebleeding in Poor-Grade Subarachnoid Hemorrhage: Results From the National POGASH Registry. Neurosurgery. 2023 Dec 1;93(6):e174-e176. doi: 10.1227/neu.0000000000002691. Epub 2023 Sep 21. No abstract available.
citation: Panni P, Riccio L, Cao R, Pedicelli A, Marchese E, Caricato A, Feletti A, Testa M, Zanatta P, Gitti N, Piva S, Mardighian D, Semeraro V, Nardin G, Lozupone E, Paiano G, Picetti E, Montanaro V, Petranca M, Bortolotti C, Scibilia A, Cirillo L, Lanterna AL, Ambrosi A, Mortini P, Beretta L, Falini A. Clinical Impact and Predictors of Aneurysmal Rebleeding in Poor-Grade Subarachnoid Hemorrhage: Results From the National POGASH Registry. Neurosurgery. 2023 Sep 1;93(3):636-645. doi: 10.1227/neu.0000000000002467. Epub 2023 Apr 3.