Status:

RECRUITING

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

Lead Sponsor:

Huashan Hospital

Conditions:

Aneurysmal Subarachnoid Hemorrhage

Intracranial Pressure Increase

Eligibility:

All Genders

18+ years

Phase:

NA

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 progno...

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 ane...

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).

Key Trial Info

Start Date :

May 20 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 30 2026

Estimated Enrollment :

372 Patients enrolled

Trial Details

Trial ID

NCT06288659

Start Date

May 20 2024

End Date

December 30 2026

Last Update

January 7 2025

Active Locations (1)

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1

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China, 200000