Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms

June 9, 2024 updated by: Revaz Dzhindzhikhadze

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultra early (<24 hours)
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.
Active Comparator: Early (24-72 hours)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding rate before anerysm clipping
Time Frame: baseline, pre-surgery
The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed.
baseline, pre-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome according to the Modified Rankin Scale
Time Frame: 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.
Up to 12 months after aneurysm surgery
Delayed cerebral ischemia
Time Frame: 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
Up to 3 weeks after aneurysm rupture
Rate of occlusion according to modified Raymond-Roy classification
Time Frame: 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.
Up to 12 months after aneurysm surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Revaz Dzhindzhikhadze

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 25, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sah_moniki

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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