Aneurysmal Subarachnoid Hemorrhage Treatment Based on Intraventricular Intracranial Pressure Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Department of Neurosurgery, Huashan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Xuehai Wu, Ph.D.
Wuxuehai2013@163.com
+8613764880571
Time Frame
Start Date:2024-05-20
Estimated Completion Date:2026-12-30
Participants
Target number of participants:372
Treatments
Experimental: aSAH treatment based on Intraventricular ICP monitoring
In the acute phase of aSAH (following endovascular or craniotomy occlusion of the aneurysm), a ventricular ICP monitoring probe is surgically implanted. And the postoperative management of ICP is guided by quantifiable ICP parameters. The remaining treatments are consistent with those in the control group.
No_intervention: aSAH treatment without Intraventricular ICP monitoring
Only aSAH treatment surgery is performed without intraventricular ICP monitoring probe implantation. The treatment is not guided by ICP monitoring, and instead, aSAH treatment is conducted based on clinical signs and CT imaging to assess ICP.