Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

Subarachnoid Hemorrhage, Aneurysmal Clinical Trial

— POGASH  

Official title:

Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945603
• Other study ID #: POGASH
• Status: Recruiting
• Start date: May 25, 2021
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: IRCCS San Raffaele
• Contact: Pietro Panni, P.I., M.D.
• Phone: +393406311389
• Email: panni.pietro[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Subarachnoid Hemorrhage, Aneurysmal

Intervention

Other:
• Standard management according to international/national guidelines
Standard management according to international/national guidelines. Observational study

Locations

Country	Name	City	State
Italy	ASST Ospedale Papa Giovanni XXIII	Bergamo
Italy	IRCCS Bellaria	Bologna
Italy	Azienda Ospedaliera Spedali Civili	Brescia
Italy	Ospedale Vito Fazzi	Lecce
Italy	IRCCS San Raffaele	Milano
Italy	Ospedale Maggiore della Città di Novara	Novara
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	Policlinico Universitario Agostino Gemelli	Roma
Italy	Ospedale Santissima Annunziata	Taranto
Italy	Azienda Ospedaliera Universitaria Integrata	Verona

Sponsors (10)

Lead Sponsor

Collaborator

IRCCS San Raffaele

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

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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, — View Citation

Outcome

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