Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457347
• Other study ID #: sah_moniki
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: Moscow Regional Research and Clinical Institute (MONIKI)
• Contact: Revaz Dzhindzhikhadze, PhD
• Phone: +79161519868
• Email: brainsurg77[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Intervention

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.
• Early (24-72 hours) ruptured aneurysm clipping
Aneurysms are clipped with open surgery in 24 to 72 hours after rupture to prevent early rebleeding.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Revaz Dzhindzhikhadze

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Stroke. 2011 Nov;42(11):e631. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rebleeding rate before anerysm clipping	The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed.	baseline, pre-surgery
Secondary	Clinical outcome according to the Modified Rankin Scale	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.; No significant disability. Able to carry out all usual activities, despite some symptoms.; Slight disability. Able to look after own affairs without assistance but unable to carry out all previous activities.; Moderate disability. Requires some help, but able to walk unassisted.; Moderately severe disability. Unable to attend to own bodily needs without assistance and unable to walk unassisted.; Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; Dead.	Up to 12 months after aneurysm surgery
Secondary	Delayed cerebral ischemia	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
Secondary	Rate of occlusion according to modified Raymond-Roy classification	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