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Recruiting NCT04945603

Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

— Observational Subarachnoid Hemorrhage, Aneurysmal Poor Grade Subarachnoid Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard management according to international/national guidelines.
Who it may be relevant to
Registry conditions: Subarachnoid Hemorrhage, Aneurysmal, Poor Grade Subarachnoid Hemorrhage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group

Overview

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).

Interventions

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

Primary outcome measures

  • Clinical Outcome [Time frame: 6 months.]
  • Clinical Outcome [Time frame: 12 months]
Secondary outcome measures (9)
  • Long-Term clinical outcome [Time frame: 12-60 months]
  • Delayed Cerebral Ischemia [Time frame: onset-30 days]
  • Rebleeding [Time frame: onset-48hours]
  • Treatment Complications [Time frame: onset-1 week]
  • Decompressive Craniotomy [Time frame: onset-3 weeks]
  • Ventriculo-peritoneal shunt [Time frame: onset-4 weeks]
  • CSF drainage [Time frame: onset-3 weeks]
  • Volumetric analysis of intracranial bleeding [Time frame: onset-24hours]
  • Volumetric analysis of delayed cerebral ischemia [Time frame: onset-3 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 10 centers
  • ASST Ospedale Papa Giovanni XXIII — Bergamo
  • IRCCS Bellaria — Bologna
  • Azienda Ospedaliera Spedali Civili — Brescia
  • Ospedale Vito Fazzi — Lecce
  • IRCCS San Raffaele — Milan
  • Ospedale Maggiore della Città di Novara — Novara
  • Azienda Ospedaliero-Universitaria di Parma — Parma
  • Policlinico Universitario Agostino Gemelli — Roma
  • … and 2 more centers

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. PMID 37732736
  • 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 PMID 37010298

Identifiers

NCT: NCT04945603 · POGASH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗