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Clinical Trials in China / NCT06288659
Active, not recruiting Not applicable

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

NCT06288659 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Not applicable
Started
2024-07-19
Last updated
2026-07-07

Condition(s) studied

Aneurysmal Subarachnoid HemorrhageIntacranial Hypertension

Investigational drug(s) / intervention(s)

Intraventricular intracranial pressure monitoring

Intraventricular 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Neurosurgery, Huashan Hospital, Fudan University Shanghai Shanghai Municipality

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06288659 on ClinicalTrials.gov ↗ ← All trials in China