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Recruiting Observational

Poor Grade Aneurysmal Subarachnoid Hemorrhage Study Group

NCT04945603 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-05-25
Last updated
2023-11-29

Condition(s) studied

Subarachnoid Hemorrhage, AneurysmalPoor Grade Subarachnoid Hemorrhage

Investigational drug(s) / intervention(s)

Standard management according to international/national guidelines

Standard management according to international/national guidelines: Standard management according to international/national guidelines. Observational study

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Clinical Outcome — 6 months.
    modified Rankin Scale
  • Clinical Outcome — 12 months
    modified Rankin Scale (mRS). Scale ranging from 0 (no symptoms) to 6 (dead) with higher scores indicating increasing neurological disability.

Trial sites (10)

FacilityCityRegionStatus
ASST Ospedale Papa Giovanni XXIII Bergamo Italy Active Not Recruiting
IRCCS Bellaria Bologna Italy Recruiting
Azienda Ospedaliera Spedali Civili Brescia Italy Recruiting
Ospedale Vito Fazzi Lecce Italy Recruiting
IRCCS San Raffaele Milan Italy Recruiting
Ospedale Maggiore della Città di Novara Novara Italy Recruiting
Azienda Ospedaliero-Universitaria di Parma Parma Italy Recruiting
Policlinico Universitario Agostino Gemelli Roma Italy Active Not Recruiting
Ospedale Santissima Annunziata Taranto Italy Recruiting
Azienda Ospedaliera Universitaria Integrata Verona Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04945603 on ClinicalTrials.gov ↗ ← All trials in Italy