Aneurizmális szubarachnoidális vérzés kezelése koponyán belüli nyomás monitorozáson alapuló (ASTIM)
Aneurizmális szubarachnoidális vérzés kezelése koponyán belüli nyomás monitorozáson alapul: Multicentrikus, randomizált, kontrollált vizsgálat
ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
Subarachnoid hemorrhage (SAH) is a severe type of cerebral hemorrhage, characterized by high mortality and disability rates. Approximately 85% of SAH cases are caused by ruptured intracranial aneurysms and are classified as aneurysmal SAH (aSAH). Improving the prognosis of patients with aSAH has become a pressing and significant issue.
The rupture of an aneurysm results in a significant amount of blood entering the subarachnoid space, triggering an increase in intracranial pressure (ICP). Elevated ICP can impair cerebral perfusion and contribute to secondary brain injury and poor functional outcomes. A systematic review and meta-analysis found that the incidence rate of elevated ICP (ICP >20 mmHg) in patients with aSAH was 70.69%, with elevated ICP being more common in patients with higher disease severity grades, including higher Hunt-Hess, WFNS, or modified Fisher grades.
Intraventricular ICP monitoring provides continuous, real-time quantitative ICP data and may facilitate a stepwise ICP-lowering strategy and goal-directed management based on quantitative ICP values. However, the role of continuous ICP monitoring and protocolized ICP-targeted management in aSAH remains uncertain, and high-quality randomized evidence remains limited. Given this evidence gap, this study was designed to determine whether a structured management strategy guided by continuous intraventricular ICP monitoring improves functional outcomes in patients with aSAH compared with standard care, and to assess the safety of this management strategy.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kína, 200000
- Department of Neurosurgery, Huashan Hospital, Fudan University
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
Inclusion criterias
- Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset.
- Age ≥ 18 years.
- Symptom onset within 72 hours.
- Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging.
- Written informed consent obtained from the participant or legal representative.
Exclusion criteria included
- Pregnancy or lactation;
- Bilateral fixed dilated pupils on admission;
- Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease;
- Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3;
- Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect;
- Subarachnoid haemorrhage caused by non-aneurysmal aetiologies;
- Moyamoya disease associated aneurysmal rupture;
- Other underlying diseases expected to substantially affect prognosis;
- Active request for ICP monitoring by the patient or family;
- Any other condition considered unsuitable for enrolment by two investigators;
- Concurrent participation in another clinical trial.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: aSAH management guided by continuous intraventricular ICP monitoring
In the acute phase of aSAH (following endovascular or microsurgical occlusion of the ruptured aneurysm), an intraventricular ICP catheter is placed for continuous ICP monitoring. Postoperative ICP management is guided by continuous quantitative ICP measurements according to a predefined ICP-targeted treatment protocol. Other guideline-based treatments are provided in the same manner as in the control group. |
The postoperative management of ICP is guided by continuous quantitative intraventricular ICP measurements according to a predefined ICP-targeted treatment protocol. The treatment target is ICP ≤20 mmHg, and a predefined stepwise ICP-lowering protocol is initiated if ICP remains >20 mmHg for more than 15 minutes. CSF drainage through the intraventricular catheter is permitted when clinically indicated. Other guideline-based treatments are provided in the same manner as in the control group. |
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Nincs beavatkozás: Guideline-based Standard Care Group
Guideline-based standard aSAH management is provided without continuous intraventricular ICP monitoring or the predefined ICP-targeted treatment protocol. ICP-related management is not guided by continuous quantitative ICP measurements and is instead based on clinical assessment, imaging findings, and treating physician judgment. Clinically indicated CSF diversion and other standard ICP-lowering treatments are permitted. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Favourable functional outcome at 3 months
Időkeret: 3 months after ictus
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The proportion of patients with modified Rankin Scale (mRS) scores of 0-2. The mRS is an ordinal scale ranging from 0 to 6, with higher scores indicating greater disability. An mRS score of 0-2 is defined as a favourable functional outcome. |
3 months after ictus
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Favourable functional outcome assessed by mRS
Időkeret: 1 month and 6 months after ictus
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Proportion of patients with mRS scores 0-2 |
1 month and 6 months after ictus
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Favourable functional outcome assessed by Glasgow Outcome Scale-Extended (GOS-E)
Időkeret: 1 month, 3 months, and 6 months after ictus
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The GOS-E is an ordinal scale ranging from 1 to 8, with lower scores indicating greater disability. A GOS-E score ≥5 is defined as a favourable functional outcome. |
1 month, 3 months, and 6 months after ictus
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All-cause mortality
Időkeret: 1 month, 3 months, and 6 months after ictus
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Proportion of patients who died. |
1 month, 3 months, and 6 months after ictus
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Symptomatic hydrocephalus requiring permanent CSF shunting
Időkeret: 3 months after ictus
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Proportion of patients with symptomatic hydrocephalus requiring ventriculoperitoneal or lumboperitoneal shunt placement. |
3 months after ictus
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Delayed cerebral ischemia (DCI)
Időkeret: 3 months after ictus
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Proportion of patients with DCI. DCI is defined according to the consensus criteria proposed by Vergouwen et al. Clinical DCI is defined as a new focal neurological impairment or a decrease of at least 2 points on the GCS, lasting for at least 1 hour, not apparent immediately after aneurysm occlusion, and not attributable to other causes. DCI-related cerebral infarction is defined as a new cerebral infarction identified on CT or MRI within 6 weeks after SAH that was absent on imaging obtained 24-48 hours after aneurysm occlusion and cannot be attributed to other causes. |
3 months after ictus
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New-onset seizures
Időkeret: 3 months after ictus
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Proportion of patients with clinically or electroencephalographically confirmed new-onset seizures. |
3 months after ictus
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Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Rebleeding
Időkeret: 3 months
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New subarachnoid, intracerebral, or intraventricular haemorrhage attributable to rerupture of the index aneurysm after randomisation, confirmed by neuroimaging. |
3 months
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Catheter tract haemorrhage
Időkeret: 3 months
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New intraparenchymal or intraventricular haemorrhage along the trajectory of an intraventricular ICP monitoring catheter or EVD after catheter placement or removal, confirmed by CT, with an estimated haemorrhage volume ≥5 mL. |
3 months
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Intracranial infection
Időkeret: 3 months
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Intracranial infection meeting the prespecified microbiological and/or clinical cerebrospinal fluid criteria, with suspected events adjudicated according to the prespecified definition. |
3 months
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Wound-related complications
Időkeret: 3 months
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Infection, dehiscence, cerebrospinal fluid leakage, or other clinically significant wound complication at the ICP monitoring catheter or EVD insertion site requiring resuturing, procedural intervention, or prolonged wound care. |
3 months
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Serious adverse events (SAEs)
Időkeret: 6 months
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All serious adverse events are systematically recorded through completion of the 6-month follow-up. |
6 months
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Együttműködők és nyomozók
Szponzor
Nyomozók
- Kutatásvezető: Wei Zhu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University
- Kutatásvezető: Xuehai Wu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University
Publikációk és hasznos linkek
Általános kiadványok
- Vergouwen 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.
- Macdonald RL, Schweizer TA. Spontaneous subarachnoid haemorrhage. Lancet. 2017 Feb 11;389(10069):655-666. doi: 10.1016/S0140-6736(16)30668-7. Epub 2016 Sep 13.
- Etminan N, Chang HS, Hackenberg K, de Rooij NK, Vergouwen MDI, Rinkel GJE, Algra A. Worldwide Incidence of Aneurysmal Subarachnoid Hemorrhage According to Region, Time Period, Blood Pressure, and Smoking Prevalence in the Population: A Systematic Review and Meta-analysis. JAMA Neurol. 2019 May 1;76(5):588-597. doi: 10.1001/jamaneurol.2019.0006.
- Neifert SN, Chapman EK, Martini ML, Shuman WH, Schupper AJ, Oermann EK, Mocco J, Macdonald RL. Aneurysmal Subarachnoid Hemorrhage: the Last Decade. Transl Stroke Res. 2021 Jun;12(3):428-446. doi: 10.1007/s12975-020-00867-0. Epub 2020 Oct 19.
- Ironside N, Buell TJ, Chen CJ, Kumar JS, Paisan GM, Sokolowski JD, Liu KC, Ding D. High-Grade Aneurysmal Subarachnoid Hemorrhage: Predictors of Functional Outcome. World Neurosurg. 2019 May;125:e723-e728. doi: 10.1016/j.wneu.2019.01.162. Epub 2019 Feb 6.
- Seule M, Oswald D, Muroi C, Brandi G, Keller E. Outcome, Return to Work and Health-Related Costs After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2020 Aug;33(1):49-57. doi: 10.1007/s12028-019-00905-2.
- Heuer GG, Smith MJ, Elliott JP, Winn HR, LeRoux PD. Relationship between intracranial pressure and other clinical variables in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Sep;101(3):408-16. doi: 10.3171/jns.2004.101.3.0408.
- Robba C, Graziano F, Rebora P, Elli F, Giussani C, Oddo M, Meyfroidt G, Helbok R, Taccone FS, Prisco L, Vincent JL, Suarez JI, Stocchetti N, Citerio G; SYNAPSE-ICU Investigators. Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study. Lancet Neurol. 2021 Jul;20(7):548-558. doi: 10.1016/S1474-4422(21)00138-1.
- Hoh 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.
- Claassen 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- KY2024-050
Terv az egyéni résztvevői adatokhoz (IPD)
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