Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group (POGASH)

Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group

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).

Study Overview

• Status: Recruiting
• Conditions: Subarachnoid Hemorrhage, Aneurysmal; Poor Grade Subarachnoid Hemorrhage
• Intervention / Treatment: Other: Standard management according to international/national guidelines

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Pietro Panni, P.I., M.D.; Phone Number: +393406311389; Email: panni.pietro@hsr.it
• Study Contact Backup: Name: Andrea Falini, Professor of Neuroradiology; Phone Number: +39 0226432239; Email: falini.andrea@hsr.it

Study Locations

• Italy
  • Bergamo, Italy, 24127
    • Active, not recruiting
    • ASST Ospedale Papa Giovanni XXIII
  • Bologna, Italy
    • Recruiting
    • IRCCS Bellaria
    • Contact: Carlo Bortolotti, MD; Email: carlo.bortolotti@isnb.it
  • Brescia, Italy, 25123
    • Recruiting
    • Azienda Ospedaliera Spedali Civili
    • Contact: Simone Piva, MD; Email: simone.piva@unibs.it
  • Lecce, Italy, 73100
    • Recruiting
    • Ospedale Vito Fazzi
    • Contact: Emilio Lozupone, MD; Email: emilio.lozupone@gmail.com
  • Milano, Italy, 20134
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Pietro Panni, P.I./MD; Phone Number: +393406311389; Email: panni.pietro@hsr.it
  • Novara, Italy
    • Recruiting
    • Ospedale Maggiore della Città di Novara
    • Contact: Rosanna Vaschetto, MD, PhD; Email: rosanna.vaschetto@med.uniupo.it
    • Principal Investigator: Rosanna Vaschetto, MD, PhD
  • Parma, Italy, 43126
    • Recruiting
    • Azienda Ospedaliero-Universitaria di Parma
    • Contact: Edoardo Picetti, MD; Email: edoardopicetti@hotmail.it
  • Roma, Italy, 00168
    • Active, not recruiting
    • Policlinico Universitario Agostino Gemelli
  • Taranto, Italy, 74121
    • Recruiting
    • Ospedale Santissima Annunziata
    • Contact: Vittorio Semeraro, MD; Email: vittoriosemeraro@hotmail.it
  • Verona, Italy, 37126
    • Recruiting
    • Azienda Ospedaliera Universitaria integrata
    • Contact: Alberto Feletti, Professor/MD; Email: alberto.feletti@univr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Poor Grade Subarachnoid Hemorrhage; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliera Universitaria Integrata Verona; Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia; Azienda Ospedaliero-Universitaria di Parma; Azienda Ospedaliero Universitaria Maggiore della Carita; A.O. Ospedale Papa Giovanni XXIII; Ospedale V. Fazzi; ASL Taranto; IRCCS Istituto delle Scienze Neurologiche di Bologna
• Investigators: Principal Investigator: Pietro Panni, P.I., M.D., Department of Neuroradiology, Department of Neurosurgery

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: POGASH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No