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

Launched by HUASHAN HOSPITAL · Feb 25, 2024

Keywords

ClinConnect Summary

The ASTIM trial is studying a new treatment approach for patients who have suffered from a brain condition called aneurysmal subarachnoid hemorrhage (aSAH), which is a type of bleeding in the brain caused by the rupture of an aneurysm. This trial will monitor the pressure inside the skull (intracranial pressure) to see if this helps improve the recovery and overall outcomes for these patients. The trial is currently looking for participants aged 18 to 70 who have experienced symptoms within the last 72 hours and have been diagnosed through imaging tests. It's important that participants are able to give consent for themselves or have their family members do so.

If you or a loved one is eligible and chooses to participate, you can expect to undergo regular checks and monitoring to help manage your condition. The trial aims to gather more information about the safety and effectiveness of this treatment method, which could lead to better care for future patients. It's crucial to know that certain health conditions or circumstances may disqualify some patients from joining, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

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).