Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms
NCT Number: NCT06457347
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Interventions: PROCEDURE: Ultra early (<24 hours) ruptured aneurysm clipping|PROCEDURE: Early (24-72 hours) ruptured aneurysm clipping
Sponsor: Revaz Dzhindzhikhadze
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-06-30

Summary:
The goal of this clinical trial is to determine the most effective timing for clipping in adults with ruptured intracranial aneurysms. It will also assess the safety of performing the surgery at different times of early period after the aneurysm has ruptured. The main questions it aims to answer are:

1. Does ultra-early surgical intervention ( less than 24 hours of rupture) improve survival rates compared to delayed surgery (24 to 72 hours after rupture)?
2. What are the complication rates associated with early versus delayed surgical intervention?

Researchers will compare clipping in ultra-early period to surgery in early period to see if timing affects the outcomes for treating ruptured intracranial aneurysms.

Participants will:

* Be randomly assigned to undergo surgical clipping either within 24 hours of rupture or between 24 hours to 72 hours after the rupture.
* Visit the clinic for follow-up assessments at 1 month, 3 months, 6 months, and 12 months post-surgery.
* Keep a diary of their symptoms, neurological function, and any complications they experience post-surgery.

Primary Outcome Measures: Rebleeding rate before anerysm clipping, The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed., baseline, pre-surgery
Secondary Outcome Measures: Clinical outcome according to the Modified Rankin Scale, Modified Rankin Scale (mRS) is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0 to 6, spanning from perfect health without symptoms to death:

0: No symptoms.

1. No significant disability. Able to carry out all usual activities, despite some symptoms.
2. Slight disability. Able to look after own affairs without assistance but unable to carry out all previous activities.
3. Moderate disability. Requires some help, but able to walk unassisted.
4. Moderately severe disability. Unable to attend to own bodily needs without assistance and unable to walk unassisted.
5. Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. Dead., Up to 12 months after aneurysm surgery|Delayed cerebral ischemia, Delayed cerebral ischemia is defined as a clinical deterioration attributed to cerebral ischemia that occurs days after an initial subarachnoid hemorrhage. This condition is characterized by a new onset of focal neurological impairment or a decrease of at least two points on the Glasgow Coma Scale, which cannot be attributed to other causes such as rebleeding, hydrocephalus, or surgical complications. The risk of delayed cerebral ischemia is lower when aneurysms are treated in less than 24 h after rupture, Up to 3 weeks after aneurysm rupture|Rate of occlusion according to modified Raymond-Roy classification, Modified Raymond-Roy Classification (mRRC) categorizes the occlusion status of an aneurysm post-treatment into three grades based on the extent of filling within the aneurysm sac seen on angiographic imaging:

Class 1 (Complete Occlusion): No opacification of the aneurysm sac is visible. This indicates a complete absence of blood flow into the aneurysm.

Class 2 (Residual Neck): A small residual contrast filling is confined to the neck of the aneurysm.

Class 3 (Residual Aneurysm): There is opacification of the aneurysm sac, indicating incomplete occlusion with more substantial contrast filling., Up to 12 months after aneurysm surgery