Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms
NCT ID: NCT06457347
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-07-01
2026-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ultra early (<24 hours)
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)
Early (24-72 hours) ruptured aneurysm clipping
Aneurysms are clipped with open surgery in 24 to 72 hours after rupture to prevent early rebleeding.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* patient eligible for surgical clipping
* patients with informed consent for inclusion into the study
Exclusion Criteria
* patients with severe comorbidities
* patients with multiple aneurysms
18 Years
ALL
No
Sponsors
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Revaz Dzhindzhikhadze
OTHER_GOV
Responsible Party
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Revaz Dzhindzhikhadze
Chief of neurosurgical department
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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sah_moniki
Identifier Type: -
Identifier Source: org_study_id
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