Subarachnoid Hemorrhage, AneurysmalPOGASHNCT04945603
Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Poor Grade Subarachnoid Hemorrhage, run by IRCCS San Raffaele at 10 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Poor Grade Subarachnoid Hemorrhage
- What is being tested?
- Standard management according to international/national guidelines
- How many people
- 800 participants
- Where
- 10 sitesItaly
- Study dates
- 25 May 2021to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.
Who cannot join
- Patients younger than 18 years old.
- Pregnant or breast-feeding patients.
- Aneurysmal subarachnoid hemorrhage due to trauma or vascular malformations other than cerebral aneurysms.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Italy10 sites, 8 recruiting
- Active, not recruiting
ASST Ospedale Papa Giovanni XXIII
Bergamo, 24127
- Recruiting
IRCCS Bellaria
Bologna
Carlo Bortolotti, MD, carlo.bortolotti@isnb.it
- Recruiting
Azienda Ospedaliera Spedali Civili
Brescia, 25123
Simone Piva, MD, simone.piva@unibs.it
- Recruiting
Ospedale Vito Fazzi
Lecce, 73100
Emilio Lozupone, MD, emilio.lozupone@gmail.com
- Recruiting
IRCCS San Raffaele
Milan, 20134
Pietro Panni, P.I./MD, +393406311389, panni.pietro@hsr.it
- Recruiting
Ospedale Maggiore della Città di Novara
Novara
Rosanna Vaschetto, MD, PhD, rosanna.vaschetto@med.uniupo.it
Rosanna Vaschetto, MD, PhD
- Recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, 43126
Edoardo Picetti, MD, edoardopicetti@hotmail.it
- Active, not recruiting
Policlinico Universitario Agostino Gemelli
Roma, 00168
- Recruiting
Ospedale Santissima Annunziata
Taranto, 74121
Vittorio Semeraro, MD, vittoriosemeraro@hotmail.it
- Recruiting
Azienda Ospedaliera Universitaria Integrata
Verona, 37126
Alberto Feletti, Professor/MD, alberto.feletti@univr.it
About this study
Official title: Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric 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:
- outcome predictors in the emergency department (so called "early brain injury phase").
- outcome predictors in the neurocritical care unit (so called "delayed brain injury phase").
- 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).
- Being tested
- Standard management according to international/national guidelines
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard management according to international/national guidelinesOther
Standard management according to international/national guidelines. Observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard management according to international/national guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
modified Rankin Scale
Measured: 6 months.
Clinical Outcome
modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.
Measured: 12 months
Secondary outcomes (9)
Long-Term clinical outcome
modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead)
Measured: 12-60 months
Delayed Cerebral Ischemia
Delayed Cerebral Ischemia
Measured: onset-30 days
Rebleeding
Rebleeding
Measured: onset-48hours
Treatment Complications
Treatment Complications
Measured: onset-1 week
Decompressive Craniotomy
Incidence, strategy (primary or secondary), predictors and clinical impact
Measured: onset-3 weeks
Ventriculo-peritoneal shunt
Incidence, strategy (primary or secondary), predictors and clinical impact
Measured: onset-4 weeks
CSF drainage
Use of external ventricular drainage or lumbar drainage according to institutional protocol. Clinical impact.
Measured: onset-3 weeks
Volumetric analysis of intracranial bleeding
Volumetric analysis and distribution assessment of intracranial bleeding. Clinical impact
Measured: onset-24hours
Volumetric analysis of delayed cerebral ischemia
Volumetric analysis and location assessment of delayed cerebral ischemia. Clinical impact
Measured: onset-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start25 May 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 800 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, Azienda Ospedaliero-Universitaria di Parma, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, A.O. Ospedale Papa Giovanni XXIII, ASL Taranto, Ospedale V. Fazzi, IRCCS Istituto delle Scienze Neurologiche di Bologna, Azienda Ospedaliero Universitaria Maggiore della Carita
- Responsible party
- Principal investigator, Pietro Panni, IRCCS San Raffaele
- Investigators
- Pietro Panni, P.I., M.D., Principal investigator, Department of Neuroradiology, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945603
- Sponsor's protocol ID
- POGASH
- Acronym
- POGASH
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 37732736Panni 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.
PubMed 37010298
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poor Grade Aneurysmal Subarachnoid Hemorrhage Multicentric Study Group
- ClinicalTrials.gov ID
- NCT04945603
- Acronym / sponsor ID
- POGASH / POGASH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, Azienda Ospedaliero-Universitaria di Parma, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, A.O. Ospedale Papa Giovanni XXIII, ASL Taranto, Ospedale V. Fazzi, IRCCS Istituto delle Scienze Neurologiche di Bologna, Azienda Ospedaliero Universitaria Maggiore della Carita
- Study start
- 25 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- outcome predictors in the emergency department (so called "early brain injury phase").
- outcome predictors in the neurocritical care unit (so called "delayed brain injury phase").
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poor Grade Subarachnoid Hemorrhage | – | Other: Standard management according to international/national guidelinesAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.
Key exclusion criteria (3 listed)
- Patients younger than 18 years old.
- Pregnant or breast-feeding patients.
- Aneurysmal subarachnoid hemorrhage due to trauma or vascular malformations other than cerebral aneurysms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard management according to international/national guidelinesStandard management according to international/national guidelines. Observational study | Other | Poor Grade Subarachnoid Hemorrhage |
Primary outcome
Clinical Outcome
Time frame: 6 months.
modified Rankin Scale
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 37732736Panni 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.
- Results publication: PubMed 37010298Panni 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pietro Panni, P.I., M.D. principal investigator
Department of Neuroradiology, Department of Neurosurgery
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Poor Grade Subarachnoid Hemorrhage, run by IRCCS San Raffaele at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pietro Panni, P.I., M.D. (+393406311389, panni.pietro@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome (time frame: 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.