Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
- Conditions
- Poor Grade Subarachnoid HemorrhageSubarachnoid Hemorrhage, Aneurysmal
- Interventions
- Other: Standard management according to international/national guidelines
- Registration Number
- NCT04945603
- Lead Sponsor
- IRCCS San Raffaele
- 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. 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Poor Grade Subarachnoid Hemorrhage Standard management according to international/national guidelines 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.
- Primary Outcome Measures
Name Time Method Clinical Outcome 12 months modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.
- Secondary Outcome Measures
Name Time Method Rebleeding onset-48hours Rebleeding
Delayed Cerebral Ischemia onset-30 days Delayed Cerebral Ischemia
Long-Term clinical outcome 12-60 months modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead)
Decompressive Craniotomy onset-3 weeks Incidence, strategy (primary or secondary), predictors and clinical impact
Treatment Complications onset-1 week Treatment Complications
CSF drainage onset-3 weeks Use of external ventricular drainage or lumbar drainage according to institutional protocol. Clinical impact.
Volumetric analysis of intracranial bleeding onset-24hours Volumetric analysis and distribution assessment of intracranial bleeding. Clinical impact
Volumetric analysis of delayed cerebral ischemia onset-3 weeks Volumetric analysis and location assessment of delayed cerebral ischemia. Clinical impact
Ventriculo-peritoneal shunt onset-4 weeks Incidence, strategy (primary or secondary), predictors and clinical impact
Trial Locations
- Locations (10)
Ospedale Vito Fazzi
🇮🇹Lecce, Italy
Azienda Ospedaliera Spedali Civili
🇮🇹Brescia, Italy
ASST Ospedale Papa Giovanni XXIII
🇮🇹Bergamo, Italy
IRCCS Bellaria
🇮🇹Bologna, Italy
Ospedale Maggiore della Città di Novara
🇮🇹Novara, Italy
Azienda Ospedaliera Universitaria Integrata
🇮🇹Verona, Italy
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
Ospedale Santissima Annunziata
🇮🇹Taranto, Italy
IRCCS San Raffaele
🇮🇹Milano, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy