RecruitingNot ApplicableNCT06288659

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


Sponsor

Huashan Hospital

Enrollment

372 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether measuring pressure inside the brain's fluid spaces (using an intraventricular pressure monitor) and adjusting treatment accordingly improves outcomes after a brain bleed caused by a ruptured aneurysm (subarachnoid hemorrhage). **You may be eligible if...** - You have been diagnosed with a subarachnoid hemorrhage (bleeding in the space around the brain) caused by a ruptured aneurysm - You are 18 or older and symptoms began within the past 72 hours - Your level of consciousness is moderate (Hunt-Hess grade 2–4) - Surgery or a procedure to repair the aneurysm is planned within 72 hours **You may NOT be eligible if...** - You are pregnant or breastfeeding - Both pupils are fixed and dilated on arrival (sign of very severe brain injury) - You have an active tumor or other serious concurrent conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntraventricular intracranial pressure monitoring

The postoperative management of ICP is guided by quantifiable Intraventricular ICP parameters. The remaining treatments are consistent with those in the control group.


Locations(1)

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06288659


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