Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

NCT ID: NCT04945603

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-25

Study Completion Date

2028-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Subarachnoid Hemorrhage, Aneurysmal Poor Grade Subarachnoid Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

Standard management according to international/national guidelines

Intervention Type OTHER

Standard management according to international/national guidelines. Observational study

Interventions

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Standard management according to international/national guidelines

Standard management according to international/national guidelines. Observational study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria di Parma

OTHER

Sponsor Role collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role collaborator

A.O. Ospedale Papa Giovanni XXIII

OTHER

Sponsor Role collaborator

ASL Taranto

OTHER

Sponsor Role collaborator

Ospedale V. Fazzi

OTHER

Sponsor Role collaborator

IRCCS Istituto delle Scienze Neurologiche di Bologna

OTHER

Sponsor Role collaborator

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Pietro Panni

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pietro Panni, P.I., M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neuroradiology, Department of Neurosurgery

Locations

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ASST Ospedale Papa Giovanni XXIII

Bergamo, , Italy

Site Status ACTIVE_NOT_RECRUITING

IRCCS Bellaria

Bologna, , Italy

Site Status RECRUITING

Azienda Ospedaliera Spedali Civili

Brescia, , Italy

Site Status RECRUITING

Ospedale Vito Fazzi

Lecce, , Italy

Site Status RECRUITING

IRCCS San Raffaele

Milan, , Italy

Site Status RECRUITING

Ospedale Maggiore della Città di Novara

Novara, , Italy

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, , Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Roma, , Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale Santissima Annunziata

Taranto, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pietro Panni, P.I., M.D.

Role: CONTACT

+393406311389

Andrea Falini, Professor of Neuroradiology

Role: CONTACT

+39 0226432239

Facility Contacts

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Carlo Bortolotti, MD

Role: primary

Simone Piva, MD

Role: primary

Emilio Lozupone, MD

Role: primary

Pietro Panni, P.I./MD

Role: primary

+393406311389

Rosanna Vaschetto, MD, PhD

Role: primary

Edoardo Picetti, MD

Role: primary

Vittorio Semeraro, MD

Role: primary

Alberto Feletti, Professor/MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 37732736 (View on PubMed)

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.

Reference Type RESULT
PMID: 37010298 (View on PubMed)

Other Identifiers

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POGASH

Identifier Type: -

Identifier Source: org_study_id