Clinical trial NCT06288659: aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Official title: Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Intracranial Pressure Increase
Keywords: Aneurysmal subarachnoid hemorrhage
Intraventricular intracranial pressure monitoring
Multicenter randomized clinical trail
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 372
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: The rate of good neurological functional prognosis
timeFrame: 90 days
Secondary outcomes:
measure: The rate of good neurological functional prognosis
timeFrame: 30 days, 180days
measure: The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: 30 days, 90 days, 180days
measure: Mortality
timeFrame: 30 days, 90 days, 180days
measure: Incidence of VP shunt-related hydrocephalus
timeFrame: 90 days
measure: Incidence of Delayed Cerebral Ischemia
timeFrame: 90 days
measure: Incidence of epilepsy
timeFrame: 90 days
Other outcomes:
measure: Incidence of intracranial infection
timeFrame: 90 days
measure: Incidence of bleeding from puncture site
timeFrame: 90 days
measure: Incidence of poor healing in surgical incisions
timeFrame: 90 days
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Neurosurgery, Huashan Hospital, Fudan University
name: Wei Zhu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, Huashan Hospital, Fudan University
name: Xuehai Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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