aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— ASTIM-MT  

Official title:

Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288659
• Other study ID #: KY2024-050
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2024
• Source: Huashan Hospital
• Contact: Xuehai Wu, Ph.D.
• Phone: +8613764880571
• Email: Wuxuehai2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Subarachnoid hemorrhage (SAH) is a severe type of cerebral hemorrhage, characterized by a high mortality and disability rate, approximately 85% of SAH cases are attributed to ruptured intracranial aneurysms (RIAs), which is called 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). This escalated ICP, coupled with the compression from the hematoma, severely impairs brain tissue function, leading to a cascade of irreversible neurological impairments, such as abnormal blood pressure, respiratory arrest, and cardiac arrest. Systematic reviews and meta-analysis found that the incidence rate of elevated ICP (ICP > 20mmHg) in post-aSAH patients was 70.69%, with higher levels (according to the Hunt-Hess scale, WFNS scale, or modified Fisher grade) being more prevalent for increased ICP.

The utilization of Intraventricular ICP monitoring in patients with aSAH offers the advantage of obtaining real-time, accurate data on intracranial pressure, enabling more precise and timely control of cranial pressure. However, there is a dearth of high-level randomized controlled trial evidence supporting the use of ICP in the treatment of aSAH. Given the potential utility of ICP monitoring in aSAH management and its current lack of high-level evidence in evidence-based medicine, we intend to pursue the research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The diagnosis of aSAH is established through the presence of SAH symptoms, confirmed by computed tomography (CT) scan or lumbar puncture, and further substantiated by cerebral angiography (CTA) or digital subtraction angiography (DSA) to identify the rupture of an intracranial aneurysm as the etiology. It is resolved to perform microsurgical clipping or endovascular therapy within 72 hours of the acute phase, along with the treatment of the ruptured aneurysm in phase I stage (excluding patients with exacerbated SAH due to intraoperative aneurysm rupture and occlusion of feeding arteries).

• The age ranged from 18 to 70 years;

• The onset of symptoms should occur within 72 hours;

• The GCS score should range from 6 to 12 points;

• Obtain the consent of the patient and their family members, and have them sign an informed consent form.

Exclusion Criteria:

• Pregnancy or lactation period;

• Patients presenting with bilateral dilated pupils upon admission;

• Patients lacking spontaneous breathing or suffering from shock;

• Patients with concurrent tumors, hemorrhagic diseases, or other severe underlying conditions (such as chronic obstructive pulmonary disease, multiple organ dysfunction syndrome, severe diabetes mellitus, congestive heart failure, and chronic kidney disease);

• Patients with a history of brain disorders or previous brain surgeries;

• Hemorrhage attributable to causes other than aneurysm;

• Aneurysmal rupture bleeding concurrent with moyamoya disease;

• Other underlying conditions that impact prognosis;

• Patients volunteering for ICP monitoring;

• Participants in other ongoing clinical trails;

• Other circumstances deemed inappropriate for inclusion (to be determined by two physicians).

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Intracranial Hypertension
• Intracranial Pressure Increase
• Subarachnoid Hemorrhage

Intervention

Device:
• Intraventricular intracranial pressure monitoring
The postoperative management of ICP is guided by quantifiable Intraventricular ICP parameters. The remaining treatments are consistent with those in the control group.

Locations

Country	Name	City	State
China	Department of Neurosurgery, Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. Erratum In: Stroke. 2023 Dec;54(12):e516. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of intracranial infection	The cerebrospinal fluid culture demonstrates positive findings for pathogenic bacteria, or the cerebrospinal fluid exhibits an elevated count of more than 1000 white blood cells with a predominance of polymorphonuclear cells, accompanied by decreased glucose levels and increased lactate levels in the cerebrospinal fluid.	90 days
Other	Incidence of bleeding from puncture site	This refers to intracranial bleeding resulting from ventricular puncture, which can be confirmed via a head CT scan.	90 days
Other	Incidence of poor healing in surgical incisions	This encompasses infection and suppuration at the ICP incision site, potentially impeding proper wound closure.	90 days
Primary	The rate of good neurological functional prognosis	The proportion of patients with modified Rankin Scale (mRS) scores 0-2. The mRS is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. A mRS = 2 indicated a good clinical outcome, and a mRS 5-6 indicated a poor clinical outcome.	90 days
Secondary	The rate of good neurological functional prognosis	Proportion of patients with modified Rankin Scale (mRS) scores 0-2	30 days, 180days
Secondary	The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E)	The GOS-E is an ordinal hierarchical scale ranging from 1 to 8, with lower scores indicating more severe disability.	30 days, 90 days, 180days
Secondary	Mortality	Proportion of patients who died.	30 days, 90 days, 180days
Secondary	Incidence of VP shunt-related hydrocephalus	Incidence of hydrocephalus requiring ventriculoperitoneal shunt within 90days.	90 days
Secondary	Incidence of Delayed Cerebral Ischemia	Proportion of delayed cerebral ischemia occurring within 90 days.	90 days
Secondary	Incidence of epilepsy	Proportion of symptomatic epilepsy occurring within 90 days.	90 days