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

Not Applicable

Recruiting

• Conditions: Aneurysmal Subarachnoid Hemorrhage; Intracranial Pressure Increase
• Interventions: Device: Intraventricular intracranial pressure monitoring

• Registration Number: NCT06288659
• Lead Sponsor: Huashan Hospital

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.

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 Timeline

• Study First Submitted: 2024-02-25
• Study First Submitted QC: 2024-02-25
• Study First Posted: 2024-03-01
• Study Start: 2024-05-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 372

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aSAH treatment based on Intraventricular ICP monitoring	Intraventricular intracranial pressure 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.

Primary Outcome Measures

Name	Time	Method
The rate of good neurological functional prognosis	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.

Secondary Outcome Measures

Name	Time	Method
Mortality	30 days, 90 days, 180days	Proportion of patients who died.
The rate of good neurological functional prognosis	30 days, 180days	Proportion of patients with modified Rankin Scale (mRS) scores 0-2
The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E)	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.
Incidence of Delayed Cerebral Ischemia	90 days	Proportion of delayed cerebral ischemia occurring within 90 days.
Incidence of VP shunt-related hydrocephalus	90 days	Incidence of hydrocephalus requiring ventriculoperitoneal shunt within 90days.
Incidence of epilepsy	90 days	Proportion of symptomatic epilepsy occurring within 90 days.

Trial Locations

Locations (1)

Department of Neurosurgery, Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China