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Clinical Trials in France / NCT07634172
Starting soon Observational

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

NCT07634172 · tracked via the Priya Life Science France tracker
Sponsor
Société Française d'Anesthésie et de Réanimation
Phase
Observational
Started
2026-06-15
Last updated
2026-06-08

Condition(s) studied

Aneurysmal Subarachnoid HaemorrhageDelayed Ischemic Neurological Deficit

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years 2. 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) 3. No objection to the use of data in accordance with 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.

Primary outcome measure(s)

  • DIND incidence — 12 months
    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

Trial sites (1)

FacilityCityRegionStatus
GHU Paris Paris France

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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 NCT07634172 on ClinicalTrials.gov ↗ ← All trials in France