RecruitingNCT06804421

Diagnosis and Treatment of Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage.

Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage: Diagnosis and Treatment


Sponsor

Fondazione IRCCS San Gerardo dei Tintori

Enrollment

1,400 participants

Start Date

Sep 28, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Recent studies state that patients affected by aneurysmal subarachnoid hemorrhage (aSAH) today survive longer because they are treated early. Unfortunately, patients often develop chronic disabling neurological deficits at a rate that is still unacceptable given the progress in the specific treatment of this pathology and the volume of systems of neurological monitoring available to date in Italy. The main cause of unfavorable neurological outcome is delayed cerebral ischemia (DCI), often resulting from symptomatic vasospasm defined as delayed neurological ischemic deficit (DIND). The incidence of DIND is not defined and is difficult to diagnose early as there is no gold standard for identifying it, nor guidelines regarding the most effective treatment. Given these gaps, the primary objective of this study is to describe the incidence of DIND in patients affected by aSAH, collecting information regarding the diagnostic imaging (neurological symptom on clinical examination or alteration on instrumental monitoring). Secondary objectives will be to evaluate the different therapeutic strategies adopted in the different participating centers and compare these strategies to mortality and short- and long-term functional neurological outcome. Furthermore, as there are no data in the literature, the Investigators want to describe the indications, usefulness and intensity of treatment in the aSAH patient in case of monitoring of parenchymal intracranial pressure.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria2

  • 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.

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Locations(33)

ASST Papa Giovanni XXIII

Bergamo, BG, Italy

IRCCS Istituto delle Scienze Neurologiche

Bologna, BO, Italy

ASST Spedali Civili

Brescia, BS, Italy

Fondazione Poliambulanza

Brescia, BS, Italy

ASST Lariana Ospedale Sant'Anna

San Fermo della Battaglia, CO, Italy

ASST Cremona

Cremona, CR, Italy

Azienda Ospedaliero-Universitaria Careggi

Florence, FI, Italy

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

ASST Lecco - Ospedale A. Manzoni

Lecco, LC, Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, Italy

ASST Ovest Milanese - Ospedale di Legnano

Legnano, MI, Italy

ASST Fatebenefratelli Sacco

Milan, MI, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

Milan, MI, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, MI, Italy

Human Research Hospital

Rozzano, MI, Italy

IRCCS San Raffaele

Segrate, MI, Italy

ASST Mantova

Mantua, MN, Italy

Azienda Ospedale-Università di Padova

Padova, PD, Italy

Azienda Ospedaliera di Perugia

Perugia, PG, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy

Azienda Ospedaliera San Camillo Forlanini

Roma, RM, Italy

Fondazione Policlinico Universitario A. Gemelli

Roma, RM, Italy

ASST Valtellina e Alto Lario

Sondrio, SO, Italy

ASL Città di Torino - Ospedale San Giovanni Bosco

Torino, TO, Italy

Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, TS, Italy

Azienda Sanitaria Universitaria Friuli Centrale

Udine, UD, Italy

ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

Varese, VA, Italy

Ospedale San Bortolo

Vicenza, VI, Italy

Azienda Ospedaliero Universitaria Integrata

Verona, VR, Italy

AOU Maggiore della Carità

Novara, Italy

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NCT06804421