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

NCT07634172 | Not Yet Recruiting

• 1 other identifier: 2026-01
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. Same as italian study, with their consent. For France addition of medical imaging

Conditions

Delayed Ischemic Neurological Deficit; Aneurysmal Subarachnoid Haemorrhage

Outcome Measures

Primary Outcomes (1)

• DIND incidence

  Calculation of the incidence of DIND in patients affected by aSAH. The presence of a suspicious alteration for DIND at the neurological clinical examination (if the patient is awake or if a sedation window is possible) or instrumental (if the clinical examination is not possible), confirmed or not by radiological examinations, will be recorded. Conditions that are considered diagnostic are discribed in the protocole for : * patient who is awake or can be awakened to undergo a clinical neurological examination * in comatose or unresponsive patients

  12 months

Secondary Outcomes (5)

• Imaging application

  12 months

• Neurological-functional outcome assessment

  12 months

• Invasive monitoring of intracranial pressure

  12 months

• Neurological-functional outcome assessment

  12 months

• Neurological-functional outcome assessment

  12 months

Study Arms (2)

Aneurysmal subarachnoid hemorrhage group

Patients diagnosed with aneurysmal subarachnoid hemorrhage.

Delayed Ischemic Neurologic Deficit Group

Patients diagnosed with aneurysmal subarachnoid hemorrhage who develop delayed ischemic neurologic deficit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with 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 in France

You may qualify if:

• Age ≥ 18 years
• Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral artery aneurysm, confirmed by cerebral CT angiography or intracranial angiography, requiring admission to an intensive care unit (ICU)
• No objection to the use of data in accordance with regulations.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société Française d'Anesthésie et de Réanimation: lead
• Fondazione IRCCS San Gerardo dei Tintori: collaborator

Study Sites (1)

GHU Paris

Paris, 75014, France

Location

Study Officials

• Aurélien Mazeraud, MD

  Société Française d'Anesthésie et de Réanimation

  STUDY CHAIR

Central Study Contacts

Edoardo Di Paolo, MD

CONTACT

0145658902; edoardo.di_paolo@ghu-paris.fr

Aurélien Mazeraud, MD

CONTACT

0145658902; a.mazeraud@ghu-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 8, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

FR (1)