About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Imaging application
Describe and analyze the variability of the diagnostic methods (clinical and instrumental examination) applied by each center to identify DIND in patients with aSAH and how this is treated.
Neurological-functional outcome assessment
Evaluate the impact of DIND and its treatment on short-term and long-term neurological-functional outcomes by mortality at 6 months and 12 months after the acute event. Assess mortality and neurological-functional outcomes (GOSE - Glasgow Outcome Scale Extended, and mRS - modified Rankin Scale) at 6 and 12 months after the acute event
Invasive monitoring of intracranial pressure
To evaluate the usefulness of invasive monitoring of intracranial pressure (ICP) in guiding the treatment of patients with SAH by comparing the variation of intracranial pressure in patients who have ICP monitoring with the intensity of the treatment applied (TIL, Therapy Intensity Level). Compare changes in intracranial pressure (ICP) in patients undergoing ICP monitoring with the intensity of the treatment received (TIL - Therapy Intensity Level)
Neurological-functional outcome assessment
Evaluate the impact of DIND and its treatment on short-term and long-term neurological-functional outcomes by neurological-functional outcome (GOSE, Glasgow Outcome Scale Extended) at 6 months and 12 months after the acute event. From GOSE=1 (death) to GOSE=8 (good recovery).
Sponsors and contacts
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Société Française d'Anesthésie et de Réanimation
Lead sponsor
Fondazione IRCCS San Gerardo dei Tintori
Collaborator
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