Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms

NCT06457347 | Not Yet Recruiting DMC

• 1 other identifier: sah_moniki
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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:

• 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

Keywords

aneurysm; subarachnoid hemorrhage; clipping; microsurgery; surgery timing

Outcome Measures

Primary Outcomes (1)

• Rebleeding rate before anerysm clipping

  The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed.

  baseline, pre-surgery

Secondary Outcomes (3)

• Clinical outcome according to the Modified Rankin Scale

  Up to 12 months after aneurysm surgery

• Delayed cerebral ischemia

  Up to 3 weeks after aneurysm rupture

• Rate of occlusion according to modified Raymond-Roy classification

  Up to 12 months after aneurysm surgery

Study Arms (2)

Ultra early (<24 hours)

EXPERIMENTAL

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

Early (24-72 hours)

ACTIVE COMPARATOR

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

Interventions

Ultra early (<24 hours) ruptured aneurysm clipping PROCEDURE

Aneurysms are clipped with open surgery in less than 24 hours after rupture to prevent early rebleeding.

Ultra early (<24 hours)

Early (24-72 hours) ruptured aneurysm clipping PROCEDURE

Aneurysms are clipped with open surgery in 24 to 72 hours after rupture to prevent early rebleeding.

Early (24-72 hours)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aneurysmal subarachnoid hemorrhage
• patient eligible for surgical clipping

You may not qualify if:

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

Sponsors & Collaborators

• Revaz Dzhindzhikhadze: lead

Related Publications (6)

• Phillips TJ, Dowling RJ, Yan B, Laidlaw JD, Mitchell PJ. Does treatment of ruptured intracranial aneurysms within 24 hours improve clinical outcome? Stroke. 2011 Jul;42(7):1936-45. doi: 10.1161/STROKEAHA.110.602888. Epub 2011 Jun 16.

  PMID: 21680909 BACKGROUND

• Tan H, Huang G, Li Z, Feng H, Wang Z, Zhao D, Tang J, Liu J. The impact of surgical timing on the management of aneurysms with acute hydrocephalus after aneurysmal subarachnoid hemorrhage. Turk Neurosurg. 2014;24(3):385-90. doi: 10.5137/1019-5149.JTN.9484-13.0.

  PMID: 24848179 BACKGROUND

• Oudshoorn SC, Rinkel GJ, Molyneux AJ, Kerr RS, Dorhout Mees SM, Backes D, Algra A, Vergouwen MD. Aneurysm treatment <24 versus 24-72 h after subarachnoid hemorrhage. Neurocrit Care. 2014 Aug;21(1):4-13. doi: 10.1007/s12028-014-9969-8.

  PMID: 24639201 BACKGROUND

• Dalbayrak S, Altas M, Arslan R. The effects of timing of aneurysm surgery on vasospasm and mortality in patients with subarachnoid hemorrhage. Acta Neurol Belg. 2011 Dec;111(4):317-20.

  PMID: 22368972 BACKGROUND

• Ross N, Hutchinson PJ, Seeley H, Kirkpatrick PJ. Timing of surgery for supratentorial aneurysmal subarachnoid haemorrhage: report of a prospective study. J Neurol Neurosurg Psychiatry. 2002 Apr;72(4):480-4. doi: 10.1136/jnnp.72.4.480.

  PMID: 11909907 BACKGROUND

• Dorhout Mees SM, Molyneux AJ, Kerr RS, Algra A, Rinkel GJ. Timing of aneurysm treatment after subarachnoid hemorrhage: relationship with delayed cerebral ischemia and poor outcome. Stroke. 2012 Aug;43(8):2126-9. doi: 10.1161/STROKEAHA.111.639690. Epub 2012 Jun 14.

  PMID: 22700527 BACKGROUND

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Revaz Dzhindzhikhadze, PhD

CONTACT

+79161519868; brainsurg77@gmail.com

Vadim Gadzhiagaev, MD

CONTACT

+7-999-528-84-10; vgadzhiagaev@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of neurosurgical department

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: June 13, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share