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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04945603
Other study ID # POGASH
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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