aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial (ASTIM-MT)

January 4, 2025 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

Recruiting

Conditions

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 Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Department of Neurosurgery, Huashan Hospital, Fudan University
        • Contact:

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 Criteria:

  • 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.

Exclusion Criteria:

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

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.
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.
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
Mortality
Time Frame: 30 days, 90 days, 180days
Proportion of patients who died.
30 days, 90 days, 180days
Incidence of VP shunt-related hydrocephalus
Time Frame: 90 days
Incidence of hydrocephalus requiring ventriculoperitoneal shunt within 90days.
90 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intracranial infection
Time Frame: 90 days
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
Incidence of bleeding from puncture site
Time Frame: 90 days
This refers to intracranial bleeding resulting from ventricular puncture, which can be confirmed via a head CT scan.
90 days
Incidence of poor healing in surgical incisions
Time Frame: 90 days
This encompasses infection and suppuration at the ICP incision site, potentially impeding proper wound closure.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

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

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)

May 20, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 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)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 4, 2025

Last Verified

January 1, 2025

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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