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

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.

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.

Inclusion criterias

1. Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset.
2. Age ≥ 18 years.
3. Symptom onset within 72 hours.
4. Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging.
5. Written informed consent obtained from the participant or legal representative.

Exclusion criteria included

1. Pregnancy or lactation;
2. Bilateral fixed dilated pupils on admission;
3. Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease;
4. Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3;
5. Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect;
6. Subarachnoid haemorrhage caused by non-aneurysmal aetiologies;
7. Moyamoya disease associated aneurysmal rupture;
8. Other underlying diseases expected to substantially affect prognosis;
9. Active request for ICP monitoring by the patient or family;
10. Any other condition considered unsuitable for enrolment by two investigators;
11. Concurrent participation in another clinical trial.