Aneurysmal Subarachnoid HaemorrhageDINTESANCT06804421
Diagnosis and Treatment of Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage.
An observational study of Aneurysmal Subarachnoid Haemorrhage and Delayed Ischemic Neurological Deficit, run by Fondazione IRCCS San Gerardo dei Tintori at 33 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Haemorrhage, Delayed Ischemic Neurological Deficit
- How many people
- 1,400 participants
- Where
- 33 sitesItaly
- Study dates
- 28 Sep 2024to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
Italy33 sites, 33 recruiting
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo, BG, 24127
Giacomo Dell'Avanzo, Dr, gdellavanzo@asst-pg23.it
Giacomo Dell'Avanzo, Dr
- Not yet recruiting
IRCCS Istituto delle Scienze Neurologiche
Bologna, BO, 40124
Alberto Castioni, Dr, carlo.castioni@unibo.it
Alberto Castioni, Dr
- Not yet recruiting
ASST Spedali Civili
Brescia, BS, 25123
Frank Rasulo, Prof., francesco.rasulo@unibs.it
Frank Rasulo, Prof.
- Not yet recruiting
Fondazione Poliambulanza
Brescia, BS, 25124
Giuseppe Natalini, Dr, giuseppe.natalini@poliambulanza.it
Giuseppe Natalini, Dr
- Not yet recruiting
ASST Cremona
Cremona, CR, 26100
Elena Grappa, Dr, e.grappa@asst-cremona.it
Elena Grappa, Dr
- Not yet recruiting
Azienda Ospedaliero-Universitaria Careggi
Florence, FI, 50134
Lisa Anicetti, Dr
Lisa Anicetti, Dr
- Not yet recruiting
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
Chiara Robba, Prof, kiarobba@gmail.com
Chiara Robba, Prof
- Not yet recruiting
ASST Lecco - Ospedale A. Manzoni
Lecco, LC, 23900
Cristina Panzeri, Dr, c.panzeri@asst-lecco.it
Cristina Panzeri, Dr
- Not yet recruiting
ASST Ovest Milanese - Ospedale di Legnano
Legnano, MI, 20025
Paola Fassini, Dr
Paola Fassini, Dr
- Not yet recruiting
ASST Mantova
Mantua, MN, 46100
Angela Berselli, Dr, angela.berselli@gmail.com
Angela Berselli, Dr
- Not yet recruiting
ASST Fatebenefratelli Sacco
Milan, MI, 20121
Elena Galassini, Dr, elena.galassini@asst-fbf-sacco.it
Elena Galassini, Dr
- Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
Tommaso Zoerle, Dr, tommaso.zoerle@policlinico.mi.it
Tommaso Zoerle, Dr
- Not yet recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20126
Arturo Chieregato, Dr, arturo.chieregato@ospedaleniguarda.it
Arturo Chieregato
- Not yet recruiting
ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
Milan, MI, 20153
Stefano Muttini, Dr, stefano.muttini@asst-santipaolocarlo.it
Stefano Muttini, Dr
- Not yet recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, MI, 20163
Marco Gemma, Dr, marco.gemma@istituto-besta.it
Marco Gemma, Dr
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
Olga De Luca, +390392332470, olga.deluca@irccs-sangerardo.it
Paola V. Gilardi, Dr
- Not yet recruiting
AOU Maggiore della Carità
Novara, 28100
Rosanna Vaschetto, Prof., rosanna.vaschetto@med.uniupo.it
Rosanna Vaschetto, Prof.
- Not yet recruiting
Azienda Ospedale-Università di Padova
Padova, PD, 35128
Marina Munari, Dr, marina.munari@aopd.veneto.it
Marina Munari, Dr
- Not yet recruiting
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126
Edoardo Picetti, Dr, edoardopicetti@hotmail.com
Edoardo Picetti, Dr
- Not yet recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100
Angelo Guglielmi, Dr, angelo.guglielmi01@universitadipavia.it
Angelo Guglielmi, Dr
- Not yet recruiting
Azienda Ospedaliera di Perugia
Perugia, PG, 06156
Angelo Giacomucci, Dr, angelo.giacomucci@ospedale.perugia.it
Angelo Giacomucci, Dr
- Not yet recruiting
Azienda Ospedaliera San Camillo Forlanini
Roma, RM, 00152
Luigi Tritapepe, Dr, ltritapepe@scamilloforlanini.rm.it
Luigi Tritapepe, Dr
- Not yet recruiting
Fondazione Policlinico Universitario A. Gemelli
Roma, RM, 00168
Anselmo Caricato, anselmo.caricato@policlinicogemelli.it
Anselmo Caricato, Prof.
- Not yet recruiting
Human Research Hospital
Rozzano, MI, 20089
Federico Villa, Dr, federico.villa@humanitas.it
Federico Villa, Dr
- Not yet recruiting
ASST Lariana Ospedale Sant'Anna
San Fermo della Battaglia, CO, 22042
Simone M Zerbi, Dr, simonemaria.zerbi@asst-lariana.it
Simone M Zerbi
- Not yet recruiting
IRCCS San Raffaele
Segrate, MI, 20132
Antonio Dell'Acqua, Dr, antonio.dellacqua@hsr.it
Antonio Dell'Acqua
- Not yet recruiting
ASST Valtellina e Alto Lario
Sondrio, SO, 23100
Fabio Sangalli, Dr
Fabio Sangalli, Dr
- Not yet recruiting
ASL Città di Torino - Ospedale San Giovanni Bosco
Torino, TO, 10128
Riccardo Raffaldi, Dr
Riccardo Raffaldi, Dr
- Not yet recruiting
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, TS, 34128
Erik Roman-Pognuz, Dr, romanpognuz.erik@gmail.com
Erik Roman-Pognuz, Dr
- Not yet recruiting
Azienda Sanitaria Universitaria Friuli Centrale
Udine, UD, 33100
Cristian Deana, Dr
Cristian Deana, Dr
- Not yet recruiting
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
Varese, VA, 21100
Luca Cabrini, Dr, luca.cabrini@asst-settelaghi.it
Luca Cabrini, Dr
- Not yet recruiting
Azienda Ospedaliero Universitaria Integrata
Verona, VR, 37126
Domenico Gelormini, Dr
Domenico Gelormini, Dr
- Not yet recruiting
Ospedale San Bortolo
Vicenza, VI, 36100
Elisa Boni, Dr
Elisa Boni, Dr
About this study
Official title: Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage: Diagnosis and Treatment
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.
Read the detailed 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aSAH group | Patients diagnosed with aneurysmal subarachnoid hemorrhage. | |
| DIND group | Patients diagnosed with aneurysmal subarachnoid hemorrhage who develop delayed ischemic neurologic deficit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
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).
Measured: 12 months
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 (mRS, modified Rankin Scale) at 6 months and 12 months after the acute event. From mRS=0 (no symptoms) to mRS=5 (severe disability).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start28 Sep 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HaemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS San Gerardo dei Tintori
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Citerio, Professor, Head od Department, Principal investigator, Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804421
- Sponsor's protocol ID
- DINTESA (4533)
- Acronym
- DINTESA
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Su YS, Ali MS, Pukenas BA, Favilla CG, Zanaty M, Hasan DM, Kung DK. Novel Treatment of Cerebral Vasospasm Using Solitaire Stent Retriever-Assisted Angioplasty: Case Series. World Neurosurg. 2020 Mar;135:e657-e663. doi: 10.1016/j.wneu.2019.12.097. Epub 2019 Dec 24.
PubMed 31881345Rass V, Helbok R. How to diagnose delayed cerebral ischaemia and symptomatic vasospasm and prevent cerebral infarction in patients with subarachnoid haemorrhage. Curr Opin Crit Care. 2021 Apr 1;27(2):103-114. doi: 10.1097/MCC.0000000000000798.
PubMed 33405414Yamaki VN, Cavalcanti DD, Figueiredo EG. Delayed Ischemic Neurologic Deficit after Aneurysmal Subarachnoid Hemorrhage. Asian J Neurosurg. 2019 Jul-Sep;14(3):641-647. doi: 10.4103/ajns.AJNS_15_19.
PubMed 31497080Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.
PubMed 20798370Wilson CD, Shankar JJ. Diagnosing Vasospasm After Subarachnoid Hemorrhage: CTA and CTP. Can J Neurol Sci. 2014 May;41(3):314-9. doi: 10.1017/s031716710001725x.
PubMed 24718816Wahood W, Rizvi AA, Alexander AY, Yolcu YU, Lanzino G, Brinjikji W, Rabinstein AA. Trends in Admissions and Outcomes for Treatment of Aneurysmal Subarachnoid Hemorrhage in the United States. Neurocrit Care. 2022 Aug;37(1):209-218. doi: 10.1007/s12028-022-01476-5. Epub 2022 Mar 18.
PubMed 35304707Krishnamurthi RV, Ikeda T, Feigin VL. Global, Regional and Country-Specific Burden of Ischaemic Stroke, Intracerebral Haemorrhage and Subarachnoid Haemorrhage: A Systematic Analysis of the Global Burden of Disease Study 2017. Neuroepidemiology. 2020;54(2):171-179. doi: 10.1159/000506396. Epub 2020 Feb 20.
PubMed 32079017Claassen J, Park S. Spontaneous subarachnoid haemorrhage. Lancet. 2022 Sep 10;400(10355):846-862. doi: 10.1016/S0140-6736(22)00938-2. Epub 2022 Aug 16.
PubMed 35985353Hoh BL, Ko NU, Amin-Hanjani S, Chou SH-Y, Cruz-Flores S, Dangayach NS, Derdeyn CP, Du R, Hanggi D, Hetts SW, Ifejika NL, Johnson R, Keigher KM, Leslie-Mazwi TM, Lucke-Wold B, Rabinstein AA, Robicsek SA, Stapleton CJ, Suarez JI, Tjoumakaris SI, Welch BG. 2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2023 Jul;54(7):e314-e370. doi: 10.1161/STR.0000000000000436. Epub 2023 May 22.
PubMed 37212182
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage: Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT06804421
- Acronym / sponsor ID
- DINTESA / DINTESA (4533)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Fondazione IRCCS San Gerardo dei TintoriUniversity, hospital or other
- Study start
- 28 Sep 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aSAH group | – | –Patients diagnosed with aneurysmal subarachnoid hemorrhage. |
| DIND group | – | –Patients diagnosed with aneurysmal subarachnoid hemorrhage who develop delayed ischemic neurologic deficit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
DIND incidence
Time frame: 12 months
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.
5 secondary outcomes
Imaging application
Time frame: 12 months
Neurological-functional outcome assessment
Time frame: 12 months
Invasive monitoring of intracranial pressure
Time frame: 12 months
Neurological-functional outcome assessment
Time frame: 12 months
Neurological-functional outcome assessment
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Results publication: PubMed 31881345Su YS, Ali MS, Pukenas BA, Favilla CG, Zanaty M, Hasan DM, Kung DK. Novel Treatment of Cerebral Vasospasm Using Solitaire Stent Retriever-Assisted Angioplasty: Case Series. World Neurosurg. 2020 Mar;135:e657-e663. doi: 10.1016/j.wneu.2019.12.097. Epub 2019 Dec 24.
- Results publication: PubMed 33405414Rass V, Helbok R. How to diagnose delayed cerebral ischaemia and symptomatic vasospasm and prevent cerebral infarction in patients with subarachnoid haemorrhage. Curr Opin Crit Care. 2021 Apr 1;27(2):103-114. doi: 10.1097/MCC.0000000000000798.
- Results publication: PubMed 31497080Yamaki VN, Cavalcanti DD, Figueiredo EG. Delayed Ischemic Neurologic Deficit after Aneurysmal Subarachnoid Hemorrhage. Asian J Neurosurg. 2019 Jul-Sep;14(3):641-647. doi: 10.4103/ajns.AJNS_15_19.
- Results publication: PubMed 20798370Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.
- Results publication: PubMed 24718816Wilson CD, Shankar JJ. Diagnosing Vasospasm After Subarachnoid Hemorrhage: CTA and CTP. Can J Neurol Sci. 2014 May;41(3):314-9. doi: 10.1017/s031716710001725x.
- Results publication: PubMed 35304707Wahood W, Rizvi AA, Alexander AY, Yolcu YU, Lanzino G, Brinjikji W, Rabinstein AA. Trends in Admissions and Outcomes for Treatment of Aneurysmal Subarachnoid Hemorrhage in the United States. Neurocrit Care. 2022 Aug;37(1):209-218. doi: 10.1007/s12028-022-01476-5. Epub 2022 Mar 18.
- Results publication: PubMed 32079017Krishnamurthi RV, Ikeda T, Feigin VL. Global, Regional and Country-Specific Burden of Ischaemic Stroke, Intracerebral Haemorrhage and Subarachnoid Haemorrhage: A Systematic Analysis of the Global Burden of Disease Study 2017. Neuroepidemiology. 2020;54(2):171-179. doi: 10.1159/000506396. Epub 2020 Feb 20.
- Results publication: PubMed 35985353Claassen J, Park S. Spontaneous subarachnoid haemorrhage. Lancet. 2022 Sep 10;400(10355):846-862. doi: 10.1016/S0140-6736(22)00938-2. Epub 2022 Aug 16.
- Results publication: PubMed 37212182Hoh BL, Ko NU, Amin-Hanjani S, Chou SH-Y, Cruz-Flores S, Dangayach NS, Derdeyn CP, Du R, Hanggi D, Hetts SW, Ifejika NL, Johnson R, Keigher KM, Leslie-Mazwi TM, Lucke-Wold B, Rabinstein AA, Robicsek SA, Stapleton CJ, Suarez JI, Tjoumakaris SI, Welch BG. 2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2023 Jul;54(7):e314-e370. doi: 10.1161/STR.0000000000000436. Epub 2023 May 22.
- Ministry of Health webisteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe Citerio, Professor, Head od Department principal investigator
Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Haemorrhage and Delayed Ischemic Neurological Deficit, run by Fondazione IRCCS San Gerardo dei Tintori at 33 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Citerio, Professor, Head of Department (+390392334316, giuseppe.citerio@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DIND incidence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06804421, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.