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Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms

NCT06457347 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-06-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Revaz Dzhindzhikhadze

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-06-30
Completion
2026-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06457347 on ClinicalTrials.gov