Diagnosis and Treatment of Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage.
DINTESA
Late Neurological Ischemic Deficit in Patients Suffering From Subarachnoid Hemorrhage: Diagnosis and Treatment
1 other identifier
observational
1,400
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2024
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2024
CompletedFirst Submitted
Initial submission to the registry
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedFebruary 3, 2025
January 1, 2025
1 year
January 20, 2025
January 27, 2025
Conditions
Outcome Measures
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.
12 months
Secondary Outcomes (5)
Imaging application
12 months
Neurological-functional outcome assessment
12 months
Invasive monitoring of intracranial pressure
12 months
Neurological-functional outcome assessment
12 months
Neurological-functional outcome assessment
12 months
Study Arms (2)
aSAH group
Patients diagnosed with aneurysmal subarachnoid hemorrhage.
DIND group
Patients diagnosed with aneurysmal subarachnoid hemorrhage who develop delayed ischemic neurologic deficit.
Eligibility Criteria
The enrolling centers are mainly located in the Lombardy region, Italy. All Lombard and selected national (from other regions) centers with neurosurgery were involved.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
ASST Papa Giovanni XXIII
Bergamo, BG, 24127, Italy
IRCCS Istituto delle Scienze Neurologiche
Bologna, BO, 40124, Italy
ASST Spedali Civili
Brescia, BS, 25123, Italy
Fondazione Poliambulanza
Brescia, BS, 25124, Italy
ASST Lariana Ospedale Sant'Anna
San Fermo della Battaglia, CO, 22042, Italy
ASST Cremona
Cremona, CR, 26100, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, FI, 50134, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132, Italy
ASST Lecco - Ospedale A. Manzoni
Lecco, LC, 23900, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900, Italy
ASST Ovest Milanese - Ospedale di Legnano
Legnano, MI, 20025, Italy
ASST Fatebenefratelli Sacco
Milan, MI, 20121, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20126, Italy
ASST Santi Paolo e Carlo - Ospedale San Carlo Borromeo
Milan, MI, 20153, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, MI, 20163, Italy
Human Research Hospital
Rozzano, MI, 20089, Italy
IRCCS San Raffaele
Segrate, MI, 20132, Italy
ASST Mantova
Mantova, MN, 46100, Italy
Azienda Ospedale-Università di Padova
Padua, PD, 35128, Italy
Azienda Ospedaliera di Perugia
Perugia, PG, 06156, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, PV, 27100, Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, RM, 00152, Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, RM, 00168, Italy
ASST Valtellina e Alto Lario
Sondrio, SO, 23100, Italy
ASL Città di Torino - Ospedale San Giovanni Bosco
Torino, TO, 10128, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, TS, 34128, Italy
Azienda Sanitaria Universitaria Friuli Centrale
Udine, UD, 33100, Italy
ASST Sette Laghi - Ospedale di Circolo e Fondazione Macchi
Varese, VA, 21100, Italy
Ospedale San Bortolo
Vicenza, VI, 36100, Italy
Azienda Ospedaliero Universitaria Integrata
Verona, VR, 37126, Italy
AOU Maggiore della Carità
Novara, 28100, Italy
Related Publications (9)
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.
PMID: 31881345RESULTRass 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.
PMID: 33405414RESULTYamaki 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.
PMID: 31497080RESULTVergouwen 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.
PMID: 20798370RESULTWilson 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.
PMID: 24718816RESULTWahood 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.
PMID: 35304707RESULTKrishnamurthi 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.
PMID: 32079017RESULTClaassen 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.
PMID: 35985353RESULTHoh 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.
PMID: 37212182RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Citerio, Professor, Head od Department
Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2025
First Posted
February 3, 2025
Study Start
September 28, 2024
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
February 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share