Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms

Revaz Dzhindzhikhadze

Status: Not yet enrolling

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Procedure: Ultra early (<24 hours) ruptured aneurysm clipping; Procedure: Early (24-72 hours) ruptured aneurysm clipping

Study type: Interventional

Funder types: Other

Identifiers

NCT06457347

sah_moniki

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aneurysmal subarachnoid hemorrhage
• patient eligible for surgical clipping
• patients with informed consent for inclusion into the study

Exclusion criteria

• patients admitted and treated >72 h after subarachnoid hemorrhage onset
• patients with severe comorbidities
• patients with multiple aneurysms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ultra early (<24 hours)

Experimental group

Treatment:

Procedure: Ultra early (<24 hours) ruptured aneurysm clipping

Early (24-72 hours)

Active Comparator group

Treatment:

Procedure: Early (24-72 hours) ruptured aneurysm clipping