Лечение аневризматического субарахноидального кровоизлияния на основе мониторинга внутричерепного давления (ASTIM)

In the acute phase of aSAH (following endovascular or microsurgical occlusion of the ruptured aneurysm), an intraventricular ICP catheter is placed for continuous ICP monitoring. Postoperative ICP management is guided by continuous quantitative ICP measurements according to a predefined ICP-targeted treatment protocol. Other guideline-based treatments are provided in the same manner as in the control group.

The postoperative management of ICP is guided by continuous quantitative intraventricular ICP measurements according to a predefined ICP-targeted treatment protocol. The treatment target is ICP ≤20 mmHg, and a predefined stepwise ICP-lowering protocol is initiated if ICP remains >20 mmHg for more than 15 minutes. CSF drainage through the intraventricular catheter is permitted when clinically indicated. Other guideline-based treatments are provided in the same manner as in the control group.

Guideline-based standard aSAH management is provided without continuous intraventricular ICP monitoring or the predefined ICP-targeted treatment protocol. ICP-related management is not guided by continuous quantitative ICP measurements and is instead based on clinical assessment, imaging findings, and treating physician judgment. Clinically indicated CSF diversion and other standard ICP-lowering treatments are permitted.

The proportion of patients with modified Rankin Scale (mRS) scores of 0-2. The mRS is an ordinal scale ranging from 0 to 6, with higher scores indicating greater disability. An mRS score of 0-2 is defined as a favourable functional outcome.

Proportion of patients with mRS scores 0-2

The GOS-E is an ordinal scale ranging from 1 to 8, with lower scores indicating greater disability. A GOS-E score ≥5 is defined as a favourable functional outcome.

Proportion of patients who died.

Proportion of patients with symptomatic hydrocephalus requiring ventriculoperitoneal or lumboperitoneal shunt placement.

Proportion of patients with DCI. DCI is defined according to the consensus criteria proposed by Vergouwen et al. Clinical DCI is defined as a new focal neurological impairment or a decrease of at least 2 points on the GCS, lasting for at least 1 hour, not apparent immediately after aneurysm occlusion, and not attributable to other causes. DCI-related cerebral infarction is defined as a new cerebral infarction identified on CT or MRI within 6 weeks after SAH that was absent on imaging obtained 24-48 hours after aneurysm occlusion and cannot be attributed to other causes.

Proportion of patients with clinically or electroencephalographically confirmed new-onset seizures.

New subarachnoid, intracerebral, or intraventricular haemorrhage attributable to rerupture of the index aneurysm after randomisation, confirmed by neuroimaging.

New intraparenchymal or intraventricular haemorrhage along the trajectory of an intraventricular ICP monitoring catheter or EVD after catheter placement or removal, confirmed by CT, with an estimated haemorrhage volume ≥5 mL.

Intracranial infection meeting the prespecified microbiological and/or clinical cerebrospinal fluid criteria, with suspected events adjudicated according to the prespecified definition.

Infection, dehiscence, cerebrospinal fluid leakage, or other clinically significant wound complication at the ICP monitoring catheter or EVD insertion site requiring resuturing, procedural intervention, or prolonged wound care.

All serious adverse events are systematically recorded through completion of the 6-month follow-up.