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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS San Gerardo dei Tintori

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

The enrolling centers are mainly located in the Lombardy region, Italy. All Lombard and selected national (from other regions) centers with neurosurgery were involved.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,400 Participants
are grouped into 2 trial groups
Group A: aSAH group
Group B: DIND group

Trial outcomes

Primary outcomes

1

DIND incidence

Describe 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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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).

Time frame
12 months
4

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).

Time frame
12 months

Other outcomes

Sponsors and contacts

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