Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Interventions
- Procedure: Early (24-72 hours) ruptured aneurysm clippingProcedure: Ultra early (<24 hours) ruptured aneurysm clipping
- Registration Number
- NCT06457347
- Lead Sponsor
- Revaz Dzhindzhikhadze
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
- aneurysmal subarachnoid hemorrhage
- patient eligible for surgical clipping
- patients with informed consent for inclusion into the study
- patients admitted and treated >72 h after subarachnoid hemorrhage onset
- patients with severe comorbidities
- patients with multiple aneurysms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early (24-72 hours) Early (24-72 hours) ruptured aneurysm clipping - Ultra early (<24 hours) Ultra early (<24 hours) ruptured aneurysm clipping -
- Primary Outcome Measures
Name Time Method Rebleeding rate before anerysm clipping baseline, pre-surgery The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed.
- Secondary Outcome Measures
Name Time Method Clinical outcome according to the Modified Rankin Scale Up to 12 months after aneurysm surgery 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.Delayed cerebral ischemia Up to 3 weeks after aneurysm rupture 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
Rate of occlusion according to modified Raymond-Roy classification Up to 12 months after aneurysm surgery 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.