Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS San Raffaele
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification.
Disqualifiers
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 population
All consecutive patients admitted to the emergency department because of aneurysmal subarachnoid hemorrhage of poor grade (IV-V) according to the WFNS classification
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Standard management according to international/national guidelines
Other interventionStandard management according to international/national guidelines. Observational study
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Poor Grade Subarachnoid Hemorrhage1 intervention
Trial outcomes
Primary outcomes
1
Clinical Outcome
modified Rankin Scale
Time frame
6 months.2
Clinical Outcome
modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.
Time frame
12 monthsSecondary outcomes
1
Long-Term clinical outcome
modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead)
Time frame
12-60 months2
Delayed Cerebral Ischemia
Delayed Cerebral Ischemia
Time frame
onset-30 days3
Rebleeding
Rebleeding
Time frame
onset-48hours4
Treatment Complications
Treatment Complications
Time frame
onset-1 weekSponsors and contacts
Click on the lead sponsor to view all of their trials.
IRCCS San Raffaele
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborator
Azienda Ospedaliero-Universitaria di Parma
Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
A.O. Ospedale Papa Giovanni XXIII
Collaborator
ASL Taranto
Collaborator
Ospedale V. Fazzi
Collaborator
IRCCS Istituto delle Scienze Neurologiche di Bologna
Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborator
Source ClinicalTrials.gov