NCT06288659

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress75%
May 2024Dec 2026

First Submitted

Initial submission to the registry

February 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

February 25, 2024

Last Update Submit

January 4, 2025

Conditions

Aneurysmal Subarachnoid HemorrhageIntracranial Pressure Increase

Keywords

Aneurysmal subarachnoid hemorrhageIntraventricular intracranial pressure monitoringMulticenter randomized clinical trail

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • The rate of good neurological functional prognosis

    30 days, 180days

  • The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E)

    30 days, 90 days, 180days

  • Mortality

    30 days, 90 days, 180days

  • Incidence of VP shunt-related hydrocephalus

    90 days

  • Incidence of Delayed Cerebral Ischemia

    90 days

  • +1 more secondary outcomes

Other Outcomes (3)

  • Incidence of intracranial infection

    90 days

  • Incidence of bleeding from puncture site

    90 days

  • Incidence of poor healing in surgical incisions

    90 days

Study Arms (2)

aSAH treatment based on Intraventricular ICP monitoring

EXPERIMENTAL

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.

Device: Intraventricular intracranial pressure monitoring

aSAH treatment without Intraventricular ICP monitoring

NO INTERVENTION

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.

Interventions

Intraventricular intracranial pressure monitoringDEVICE

The postoperative management of ICP is guided by quantifiable Intraventricular ICP parameters. The remaining treatments are consistent with those in the control group.

aSAH treatment based on Intraventricular ICP monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of aSAH: presence of SAH symptoms, confirmed by CT scan or lumbar puncture. CTA or DSA confirms ruptured intracranial aneurysm (IA) as the cause. Decision made to perform craniotomy clipping or endovascular treatment within 72 hours aiming for a single procedure to cure the bleeding artery aneurysm;
  • Age ≥ 18 years;
  • The onset of symptoms should occur within 72 hours;
  • The Hunt-Hess grade is between 2 and 4, and the CT imaging findings correspond to a modified Fisher grade of 2 to 4.
  • Obtain the consent of the patient and their family members, and have them sign an informed consent form.

You may not qualify if:

  • Pregnancy or lactation period;
  • Patients presenting with bilateral dilated pupils upon admission;
  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (8)

  • 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: 27637674BACKGROUND

  • 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: 30659573BACKGROUND

  • 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: 33078345BACKGROUND

  • 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: 30735864BACKGROUND

  • 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: 31919809BACKGROUND

  • 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: 37212182BACKGROUND

  • 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: 15352597BACKGROUND

  • 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: 34146513BACKGROUND

MeSH Terms

Conditions

Subarachnoid HemorrhageIntracranial Hypertension

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological 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

Central Study Contacts

Xuehai Wu, Ph.D.

CONTACT

+8613764880571Wuxuehai2013@163.com

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

May 20, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)