Understanding and treating neurological deficits after brain hemorrhage.
Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage: Diagnosis and Treatment
This study looks at how often people with brain bleeding from an aneurysm experience delayed neurological problems and aims to find better ways to treat them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS San Gerardo dei Tintori Academic / other |
| Locations | 33 sites (Bergamo, BG and 32 other locations) |
| Trial ID | NCT06804421 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the incidence of delayed ischemic neurological deficits (DIND) in patients who have suffered from aneurysmal subarachnoid hemorrhage (aSAH). It will collect data on diagnostic imaging and clinical symptoms to better understand the occurrence and treatment of DIND, which is a significant cause of long-term disability in these patients. The study will involve patients aged 18 and older who have been diagnosed with aSAH and require intensive care. By identifying the incidence and characteristics of DIND, the study seeks to improve patient outcomes and treatment protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with subarachnoid hemorrhage due to a ruptured cerebral artery aneurysm.
Not a fit: Patients under 18 years old or those with subarachnoid hemorrhage from non-aneurysmal causes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients suffering from neurological deficits after aSAH.
How similar studies have performed: While the study addresses a significant gap in understanding DIND, similar studies have not yet established a gold standard for diagnosis or treatment, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral artery aneurysm confirmed by cerebral angiotomography or angiography of the intracranial vessels, with the need for admission to the Intensive Care Unit * Signing the Informed Consent form to participate in the study according to current local regulations. Exclusion Criteria: * Age \< 18 years * Primary diagnosis of subarachnoid hemorrhage sine materia, i.e. post-traumatic or caused by arteriovenous malformation or bleeding from a brain tumor.
Where this trial is running
Bergamo, BG and 32 other locations
- ASST Papa Giovanni XXIII — Bergamo, Bg, Italy (Not_yet_recruiting)
- IRCCS Istituto delle Scienze Neurologiche — Bologna, Bo, Italy (Not_yet_recruiting)
- ASST Spedali Civili — Brescia, Bs, Italy (Not_yet_recruiting)
- Fondazione Poliambulanza — Brescia, Bs, Italy (Not_yet_recruiting)
- ASST Lariana Ospedale Sant'Anna — San Fermo della Battaglia, Co, Italy (Not_yet_recruiting)
- ASST Cremona — Cremona, Cr, Italy (Not_yet_recruiting)
- Azienda Ospedaliero-Universitaria Careggi — Florence, Fi, Italy (Not_yet_recruiting)
- IRCCS Ospedale Policlinico San Martino — Genova, Ge, Italy (Not_yet_recruiting)
- ASST Lecco - Ospedale A. Manzoni — Lecco, Lc, Italy (Not_yet_recruiting)
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Mb, Italy (Recruiting)
- ASST Ovest Milanese - Ospedale di Legnano — Legnano, Mi, Italy (Not_yet_recruiting)
- ASST Fatebenefratelli Sacco — Milan, Mi, Italy (Not_yet_recruiting)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, Mi, Italy (Not_yet_recruiting)
- ASST Grande Ospedale Metropolitano Niguarda — Milan, Mi, Italy (Not_yet_recruiting)
- ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo — Milan, Mi, Italy (Not_yet_recruiting)
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan, Mi, Italy (Not_yet_recruiting)
- Human Research Hospital — Rozzano, Mi, Italy (Not_yet_recruiting)
- IRCCS San Raffaele — Segrate, Mi, Italy (Not_yet_recruiting)
- ASST Mantova — Mantua, Mn, Italy (Not_yet_recruiting)
- Azienda Ospedale-Università di Padova — Padova, Pd, Italy (Not_yet_recruiting)
- Azienda Ospedaliera di Perugia — Perugia, Pg, Italy (Not_yet_recruiting)
- Azienda Ospedaliero-Universitaria di Parma — Parma, Pr, Italy (Not_yet_recruiting)
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pv, Italy (Not_yet_recruiting)
- Azienda Ospedaliera San Camillo Forlanini — Roma, Rm, Italy (Not_yet_recruiting)
- Fondazione Policlinico Universitario A. Gemelli — Roma, Rm, Italy (Not_yet_recruiting)
- ASST Valtellina e Alto Lario — Sondrio, So, Italy (Not_yet_recruiting)
- ASL Città di Torino - Ospedale San Giovanni Bosco — Torino, To, Italy (Not_yet_recruiting)
- Azienda Sanitaria Universitaria Giuliano Isontina — Trieste, Ts, Italy (Not_yet_recruiting)
- Azienda Sanitaria Universitaria Friuli Centrale — Udine, Ud, Italy (Not_yet_recruiting)
- ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi — Varese, VA, Italy (Not_yet_recruiting)
- Ospedale San Bortolo — Vicenza, Vi, Italy (Not_yet_recruiting)
- Azienda Ospedaliero Universitaria Integrata — Verona, Vr, Italy (Not_yet_recruiting)
- AOU Maggiore della Carità — Novara, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Giuseppe Citerio, Professor, Head od Department — Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy
- Study coordinator: Giuseppe Citerio, Professor, Head of Department
- Email: giuseppe.citerio@unimib.it
- Phone: +390392334316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.