NCT04945603

Brief 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. 1.outcome predictors in the emergency department (so called "early brain injury phase").
  2. 2.outcome predictors in the neurocritical care unit (so called "delayed brain injury phase").
  3. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
May 2021Dec 2028

Study Start

First participant enrolled

May 25, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

4.6 years

First QC Date

June 15, 2021

Last Update Submit

November 24, 2023

Conditions

Subarachnoid Hemorrhage, AneurysmalPoor Grade Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Long-Term clinical outcome

    12-60 months

  • Delayed Cerebral Ischemia

    onset-30 days

  • Rebleeding

    onset-48hours

  • Treatment Complications

    onset-1 week

  • Decompressive Craniotomy

    onset-3 weeks

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

Standard management according to international/national guidelinesOTHER

Standard management according to international/national guidelines. Observational study

Poor Grade Subarachnoid Hemorrhage

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.

You may not qualify if:

  • Patients younger than 18 years old.
  • Pregnant or breast-feeding patients.
  • Aneurysmal subarachnoid hemorrhage due to trauma or vascular malformations other than cerebral aneurysms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

ASST Ospedale Papa Giovanni XXIII

Bergamo, 24127, Italy

ACTIVE NOT RECRUITING

IRCCS Bellaria

Bologna, Italy

RECRUITING

Azienda Ospedaliera Spedali Civili

Brescia, 25123, Italy

RECRUITING

Ospedale Vito Fazzi

Lecce, 73100, Italy

RECRUITING

IRCCS San Raffaele

Milan, 20134, Italy

RECRUITING

Ospedale Maggiore della Città di Novara

Novara, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli

Roma, 00168, Italy

ACTIVE NOT RECRUITING

Ospedale Santissima Annunziata

Taranto, 74121, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata

Verona, 37126, Italy

RECRUITING

Related 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.

    PMID: 37732736BACKGROUND

  • 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.

    PMID: 37010298RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pietro Panni, P.I., M.D.

    Department of Neuroradiology, Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+393406311389panni.pietro@hsr.it

Andrea Falini, Professor of Neuroradiology

CONTACT

+39 0226432239falini.andrea@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 30, 2021

Study Start

May 25, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2028

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

IT(10)