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

NCT06288659 | Active Not Recruiting DMC

• 1 other identifier: KY2024-050
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intacranial Hypertension; Aneurysmal Subarachnoid Hemorrhage

Keywords

Aneurysmal subarachnoid hemorrhage; Intracranial pressure monitoring-guided management; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Favourable functional outcome at 3 months

  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

Secondary Outcomes (6)

• Favourable functional outcome assessed by mRS

  1 month and 6 months after ictus

• Favourable functional outcome assessed by Glasgow Outcome Scale-Extended (GOS-E)

  1 month, 3 months, and 6 months after ictus

• All-cause mortality

  1 month, 3 months, and 6 months after ictus

• Symptomatic hydrocephalus requiring permanent CSF shunting

  3 months after ictus

• Delayed cerebral ischemia (DCI)

  3 months after ictus

Other Outcomes (5)

• Rebleeding

  3 months

• Catheter tract haemorrhage

  3 months

• Intracranial infection

  3 months

Study Arms (2)

aSAH management guided by continuous intraventricular ICP monitoring

EXPERIMENTAL

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.

Other: Intraventricular ICP monitoring-guided management

Guideline-based Standard Care Group

NO INTERVENTION

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.

Interventions

Intraventricular ICP monitoring-guided management OTHER

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.

aSAH management guided by continuous intraventricular ICP monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (10)

• 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.

  PMID: 20798370 BACKGROUND

• 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.

  PMID: 35985353 BACKGROUND

• 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.

  PMID: 27637674 BACKGROUND

• 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.

  PMID: 30659573 BACKGROUND

• 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.

  PMID: 33078345 BACKGROUND

• 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.

  PMID: 30735864 BACKGROUND

• 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.

  PMID: 31919809 BACKGROUND

• 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.

  PMID: 37212182 BACKGROUND

• 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.

  PMID: 15352597 BACKGROUND

• 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.

  PMID: 34146513 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Zhu, Ph.D.

  Department of Neurosurgery, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• Xuehai Wu, Ph.D.

  Department of Neurosurgery, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of neurosurgery department, Huashan Hospital, Fudan University

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: July 19, 2024
• Primary Completion: July 29, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)