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

Last updated: January 27, 2025
Sponsor: Fondazione IRCCS San Gerardo dei Tintori
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Occlusions

Stroke

Treatment

N/A

Clinical Study ID

NCT06804421
DINTESA (4533)
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral arteryaneurysm confirmed by cerebral angiotomography or angiography of the intracranialvessels, with the need for admission to the Intensive Care Unit

  • Signing the Informed Consent form to participate in the study according to currentlocal regulations.

Exclusion

Exclusion Criteria:

  • Age < 18 years

  • Primary diagnosis of subarachnoid hemorrhage sine materia, i.e. post-traumatic orcaused by arteriovenous malformation or bleeding from a brain tumor.

Study Design

Total Participants: 1400
Study Start date:
September 28, 2024
Estimated Completion Date:
October 31, 2026

Study Description

Aneurysmal subarachnoid hemorrhage (aSAH) is a particular form of hemorrhagic stroke characterized by blood spillage into the intracranial subarachnoid spaces due to the rupture of an aneurysm of a large cerebral arterial vessel of the circle of Willis. It can cause sudden and intense symptoms, such as violent headache, nausea, vomiting, neck stiffness and sensitivity to light, but also loss of consciousness, cardiac arrest and death.

The pre-hospital mortality rate in the literature remains high (22-26%), even if it is lower than in previous decades. However, the number of patients discharged from hospital with permanent disabilities is increasing, especially those of working age (the average age at onset of symptoms is 55 years), contributing significantly to public health costs.

The incidence of aSAH worldwide is approximately 6.1 cases per 100,000 people per year, but there are national differences. In Italy, for example, it is 11.2 (10.5-12.4) cases per 100,000 inhabitants per year.

At the onset of symptoms, once the aneurysmal origin of the cerebral hemorrhage has been confirmed through radiological examinations, it is essential to promptly ensure treatment of the ruptured aneurysm. Early repair of the ruptured aneurysm is recommended within 24 to 72 hours, via endovascular coiling or neurosurgical clipping. This allows to prevent any rebleeding and reduce the risk of cerebral vasospasm, as it reduces the amount of blood distributed in the subarachnoid space. The latter, in fact, represents the main inflammatory stimulus on large cerebral arteries, favoring the vasoconstriction reaction which manifests itself angiographically and/or ultrasonographically in 70% of cases. Cerebral vasospasm is very often clinically silent, since the reduction of the vascular lumen is not sufficient to generate the conditions of discrepancy between the arterial flow of the perfused brain parenchyma and its metabolic demand.

However, in 20-30% of cases a neurological deterioration also occurs, called delayed ischemic neurological deficit or DIND (Delayed Ischemic Neurological Deficit), defined as a focal neurological deterioration (appearance of at least one of the symptoms including hemiparesis, aphasia, hemianopsia or neglect) or global (sudden neurological worsening leading to at least a two-point decrease in the Glasgow Scale or the appearance of anisocoria or pupillary reactivity). DIND is not always immediately evident after securing the aneurysm, and it is necessary to exclude other causes of neurological deterioration, such as hydrocephalus, convulsions, rebleeding and hyponatremia in order to confirm it.

Identifying DIND early is essential to prevent the formation of a true ischemic core in the area affected by vasospasm, i.e. late cerebral ischemia, DCI (Delayed Cerebral Ischemia), defined by radiological criteria: evidence of cerebral infarction on brain computed tomography (CT) scan or brain magnetic resonance imaging (MRI) within 6 weeks of onset of aSAH complicated by vasospasm.

DIND, in fact, is the main preventable cause of unfavorable neurological-functional outcome and DCI in patients with SAH.

Regarding the identification of DIND, it is certainly crucial to carry out a systematic clinical neurological examination on the awake patient. In comatose patients, or in those in whom it is not possible to carry out a sedation window, multimodal instrumental monitoring is certainly helpful. In fact, if the patient is sedated or cannot be awakened, the information deriving from the inspection (pupillary reactivity and isocoria) should be integrated with continuous electroencephalographic monitoring (cEEG) and/or transcranial color Doppler ultrasound (TCD)ccc. Instrumental monitoring is, in fact, fundamental in those patients in whom a suspension of sedation generates an increase in intracranial pressure and consequent reduction in cerebral oxygenation, making clinical neurological evaluation impossible.

The alterations associated with DIND most commonly described during quantitative EEG (qEEG) are decreased alpha/delta ratio and reduced alpha variability. EEG changes may precede clinical deterioration by several hours, and allow for a differential diagnosis with nonconvulsive status epilepticus. Instrumental vasospasm is defined as an average blood flow velocity > 120 cm/sec detected ultrasonographically via TCD. Instead, clinical vasospasm, i.e. DIND that requires treatment, is diagnosed in case of speed of at least 200 cm/sec, or increased by 50 cm/sec in the last 24 hours, or even if the Lindeegard index is greater of 3 (defined as the ratio of flow velocities between the middle cerebral artery and the ipsilateral distal internal carotid artery, MCA/ICA).

Regarding second-level tests, in sedated or unconscious patients, it is also reasonable to perform screening through repeated imaging tests, such as computed perfusion tomography (CTP), cerebral angiotomography (CTA) and intracranial vessel angiography ( TSA). The use of CTP is increasingly widespread: it detects imminent ischemia by decreasing cerebral perfusion, thus identifying salvageable brain tissue (ischemic penumbra) before irreversible brain damage occurs. This approach, however, involves transporting the critically ill patient to radiology and administering a contrast medium, adding considerable risks. It should also be underlined that, in case of clinical or instrumental suspicion of DIND, in some centers second level tests are used less and less, intervening early with therapy to resolve it.

As with the diagnostic procedure, the therapeutic strategies implemented are also very different from each other, and none has been proven to be more effective than another. They can be more or less invasive, and the main ones are:

  • hemodynamic therapy, i.e. permissive hypertension, in which systemic blood pressure is increased to increase cerebral perfusion and ensure that an adequate quantity of blood supplies the brain parenchyma downstream of vasospasm;

  • local intra-arterial pharmacological therapy, in bolus or continuous infusion, with a vasodilator drug (calcium antagonist/milrinone);

  • mechanical therapy, whereby action is taken on the muscular wall of the vessel in question by carrying out angioplasty with a transluminal balloon.

Innovative techniques, such as stent retriever angioplasty, which also allows the application of intra-arterial calcium channel antagonists, can be an additional tool in selected patients with refractory vasospasm.

To date, there is no gold standard for diagnosing DIND, evidence on which patients are at greatest risk of developing it and recommendations regarding the most effective treatment to resolve it. Management is delegated to the multidisciplinary department team of each centre.

In conclusion, also in light of the recent guidelines on aSAH, it is urgent to establish how to prevent DCI, identifying the onset of DIND early, both clinically and instrumentally.

With this study the Investoigators aim to determine the incidence of DIND in patients with aSAH, to evaluate the effectiveness of different treatments and to compare the different diagnostic/therapeutic strategies in the participating centers, investigating the impact of DIND on short-term and long-term neurological-functional outcomes.

Connect with a study center

  • ASST Papa Giovanni XXIII

    Bergamo, BG 24127
    Italy

    Site Not Available

  • IRCCS Istituto delle Scienze Neurologiche

    Bologna, BO 40124
    Italy

    Site Not Available

  • ASST Spedali Civili

    Brescia, BS 25123
    Italy

    Site Not Available

  • Fondazione Poliambulanza

    Brescia, BS 25124
    Italy

    Site Not Available

  • ASST Lariana Ospedale Sant'Anna

    San Fermo della Battaglia, CO 22042
    Italy

    Site Not Available

  • ASST Cremona

    Cremona, CR 26100
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria Careggi

    Firenze, FI 50134
    Italy

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino

    Genova, GE 16132
    Italy

    Site Not Available

  • ASST Lecco - Ospedale A. Manzoni

    Lecco, LC 23900
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, MB 20900
    Italy

    Active - Recruiting

  • ASST Ovest Milanese - Ospedale di Legnano

    Legnano, MI 20025
    Italy

    Site Not Available

  • ASST Fatebenefratelli Sacco

    Milan, MI 20121
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI 20126
    Italy

    Site Not Available

  • ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo

    Milan, MI 20153
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, MI 20122
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, MI 20163
    Italy

    Site Not Available

  • Human Research Hospital

    Rozzano, MI 20089
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Segrate, MI 20132
    Italy

    Site Not Available

  • ASST Mantova

    Mantova, MN 46100
    Italy

    Site Not Available

  • Azienda Ospedale-Università di Padova

    Padova, PD 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera di Perugia

    Perugia, PG 06156
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, PR 43126
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, PV 27100
    Italy

    Site Not Available

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, RM 00152
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli

    Roma, RM 00168
    Italy

    Site Not Available

  • ASST Valtellina e Alto Lario

    Sondrio, SO 23100
    Italy

    Site Not Available

  • ASL Città di Torino - Ospedale San Giovanni Bosco

    Torino, TO 10128
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Trieste, TS 34128
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, UD 33100
    Italy

    Site Not Available

  • ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi

    Varese, VA 21100
    Italy

    Site Not Available

  • Ospedale San Bortolo

    Vicenza, VI 36100
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Integrata

    Verona, VR 37126
    Italy

    Site Not Available

  • AOU Maggiore della Carità

    Novara, 28100
    Italy

    Site Not Available

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