Treatment for aneurysmal subarachnoid hemorrhage using intracranial pressure monitoring

Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial

This study is testing if monitoring pressure inside the brain can help improve recovery for patients with bleeding in the brain caused by a burst aneurysm.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 372 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06288659 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of using intraventricular intracranial pressure (ICP) monitoring to improve outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH). It is a multicenter, prospective, randomized, and blinded trial that aims to provide real-time data on ICP to enable timely interventions. The study focuses on patients diagnosed with aSAH who are undergoing treatment for ruptured intracranial aneurysms. By monitoring ICP, the trial seeks to enhance the management of elevated intracranial pressure, which is a common complication in these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of aSAH and a Hunt-Hess grade between 2 and 4.

Not a fit: Patients who are pregnant, have severe underlying conditions, or present with bilateral dilated pupils upon admission may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the prognosis and quality of life for patients suffering from aneurysmal subarachnoid hemorrhage.

How similar studies have performed: While there is limited high-level evidence supporting the use of ICP monitoring in aSAH management, this trial aims to fill that gap and could provide valuable insights.

Eligibility criteria

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).

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Neurosurgery, Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Wei Zhu, Ph.D. — Department of Neurosurgery, Huashan Hospital, Fudan University
• Study coordinator: Xuehai Wu, Ph.D.

Conditions Aneurysmal Subarachnoid Hemorrhage; Intracranial Pressure Increase; Aneurysmal subarachnoid hemorrhage; Intraventricular intracranial pressure monitoring; Multicenter randomized clinical trail