NCT06457347

Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms

Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms: A Randomized Controlled Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Revaz Dzhindzhikhadze · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aneurysmal Subarachnoid Hemorrhage

Interventions

Type	Name	Description
PROCEDURE	Ultra early (<24 hours) ruptured aneurysm clipping	Aneurysms are clipped with open surgery in less than 24 hours after rupture to prevent early rebleeding.
PROCEDURE	Early (24-72 hours) ruptured aneurysm clipping	Aneurysms are clipped with open surgery in 24 to 72 hours after rupture to prevent early rebleeding.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-30
• Completion: 2026-06-30
• First posted: 2024-06-13
• Last updated: 2024-06-13