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NCT Number: NCT04945603

Poor Grade Aneurysmal Subarachnoid Hemorrhage 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).

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Key information

Conditions

Subarachnoid Hemorrhage, Aneurysmal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Poor Grade Subarachnoid Hemorrhage Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Ospedale Papa Giovanni XXIII, Bergamo, Italy

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard management according to international/national guidelines

Other

Standard management according to international/national guidelines. Observational study

Primary outcomes

  1. Clinical Outcome

    Time frame: 6 months.

    modified Rankin Scale

  2. Clinical Outcome

    Time frame: 12 months

    modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.

Secondary outcomes

  1. Long-Term clinical outcome

    Time frame: 12-60 months

    modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead)

  2. Delayed Cerebral Ischemia

    Time frame: onset-30 days

    Delayed Cerebral Ischemia

  3. Rebleeding

    Time frame: onset-48hours

    Rebleeding

  4. Treatment Complications

    Time frame: onset-1 week

    Treatment Complications

  5. Decompressive Craniotomy

    Time frame: onset-3 weeks

    Incidence, strategy (primary or secondary), predictors and clinical impact

  6. Ventriculo-peritoneal shunt

    Time frame: onset-4 weeks

    Incidence, strategy (primary or secondary), predictors and clinical impact

  7. CSF drainage

    Time frame: onset-3 weeks

    Use of external ventricular drainage or lumbar drainage according to institutional protocol. Clinical impact.

  8. Volumetric analysis of intracranial bleeding

    Time frame: onset-24hours

    Volumetric analysis and distribution assessment of intracranial bleeding. Clinical impact

  9. Volumetric analysis of delayed cerebral ischemia

    Time frame: onset-3 weeks

    Volumetric analysis and location assessment of delayed cerebral ischemia. Clinical impact

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Falini, Professor of Neuroradiology

CONTACT

[email protected]

+39 0226432239

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

CONTACT

[email protected]

+393406311389

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • 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

Registry information

Official study title

Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group

Acronym: POGASH

Important dates

Study start
2021
Primary completion
2025
Study completion
2028
First posted
Jun 30, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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