aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial (ASTIM)
July 2, 2026 updated by: Wei Zhu, Huashan Hospital
Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
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.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
372
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200000
- Department of Neurosurgery, Huashan Hospital, Fudan University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: aSAH treatment based on Intraventricular ICP monitoring
In the acute phase of aSAH (following endovascular or craniotomy occlusion of the aneurysm), a ventricular ICP monitoring probe is surgically implanted.
And the postoperative management of ICP is guided by quantifiable ICP parameters.
The remaining treatments are consistent with those in the control group.
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The postoperative management of ICP is guided by quantifiable Intraventricular ICP parameters.
The remaining treatments are consistent with those in the control group.
|
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No Intervention: aSAH treatment without Intraventricular ICP monitoring
Only aSAH treatment surgery is performed without intraventricular ICP monitoring probe implantation.
The treatment is not guided by ICP monitoring, and instead, aSAH treatment is conducted based on clinical signs and CT imaging to assess ICP.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of good neurological functional prognosis
Time Frame: 90 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The rate of good neurological functional prognosis
Time Frame: 30 days, 180days
|
Proportion of patients with modified Rankin Scale (mRS) scores 0-2
|
30 days, 180days
|
|
The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E)
Time Frame: 30 days, 90 days, 180days
|
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
|
|
Incidence of Delayed Cerebral Ischemia
Time Frame: 90 days
|
Proportion of delayed cerebral ischemia occurring within 90 days.
|
90 days
|
|
Incidence of epilepsy
Time Frame: 90 days
|
Proportion of symptomatic epilepsy occurring within 90 days.
|
90 days
|
|
All-cause mortality
Time Frame: 90 days
|
Proportion of patients who died.
|
90 days
|
|
Incidence of hydrocephalus
Time Frame: 90 days
|
Incidence of symptomatic hydrocephalus requiring surgical intervention
|
90 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rebleeding
Time Frame: 90 days
|
Rebleeding related to aneurysmal rupture confirmed by imaging
|
90 days
|
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Catheter tract haemorrhage
Time Frame: 90 days
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Catheter tract haemorrhage associated with ICP monitoring or external ventricular drainage
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90 days
|
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Intracranial infection
Time Frame: 90 days
|
Intracranial infection, defined by clinical symptoms and cerebrospinal fluid findings consistent with infection, adjudicated by the Clinical Event Adjudication Committee
|
90 days
|
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Wound-related complications
Time Frame: 90 days
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Wound-related complications, including infection, dehiscence, or cerebrospinal fluid leakage requiring intervention
|
90 days
|
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Failure of ICP control
Time Frame: 90 days
|
Defined as sustained intracranial hypertension requiring definitive surgical intervention, such as decompressive craniectomy
|
90 days
|
|
Symptomatic hydrocephalus
Time Frame: 90days
|
Symptomatic hydrocephalus requiring shunt surgery
|
90days
|
|
Seizures
Time Frame: 90 days
|
Seizures confirmed clinically or by electroencephalography
|
90 days
|
|
Deep vein thrombosis
Time Frame: 90 days
|
Deep vein thrombosis confirmed by imaging and requiring treatment
|
90 days
|
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Severe sepsis or septic shock
Time Frame: 90 days
|
Severe sepsis or septic shock resulting in organ dysfunction
|
90 days
|
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Other unexpected serious adverse events
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wei Zhu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University
- Principal Investigator: Xuehai Wu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 19, 2024
Primary Completion (Estimated)
July 29, 2026
Study Completion (Estimated)
October 30, 2026
Study Registration Dates
First Submitted
February 25, 2024
First Submitted That Met QC Criteria
February 25, 2024
First Posted (Actual)
March 1, 2024
Study Record Updates
Last Update Posted (Actual)
July 7, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY2024-050
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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