Aneurysmal Subarachnoid HemorrhageNCT06457347
Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms
A study testing Ultra early (<24 hours) ruptured aneurysm clipping and Early (24-72 hours) ruptured aneurysm clipping in people with Aneurysmal Subarachnoid Hemorrhage, run by Revaz Dzhindzhikhadze.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Ultra early (<24 hours) ruptured aneurysm clipping and Early (24-72 hours) ruptured aneurysm clipping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aneurysmal subarachnoid hemorrhage
- patient eligible for surgical clipping
- patients with informed consent for inclusion into the study
Who cannot join
- patients admitted and treated >72 h after subarachnoid hemorrhage onset
- patients with severe comorbidities
- patients with multiple aneurysms
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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:
- Does ultra-early surgical intervention ( less than 24 hours of rupture) improve survival rates compared to delayed surgery (24 to 72 hours after rupture)?
- What are the complication rates associated with early versus delayed surgical intervention?
Read more
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
- Being tested
- Ultra early (<24 hours) ruptured aneurysm clipping, Early (24-72 hours) ruptured aneurysm clipping
- Keywords
- aneurysm, subarachnoid hemorrhage, clipping, microsurgery, surgery timing
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra early (<24 hours) ruptured aneurysm clippingProcedure or surgery
Aneurysms are clipped with open surgery in less than 24 hours after rupture to prevent early rebleeding.
Early (24-72 hours) ruptured aneurysm clippingProcedure or surgery
Aneurysms are clipped with open surgery in 24 to 72 hours after rupture to prevent early rebleeding.
| Study group | Role | What they receive |
|---|---|---|
| Ultra early (<24 hours) | Experimental | Not described Receives: Procedure: Ultra early (<24 hours) ruptured aneurysm clipping |
| Early (24-72 hours) | Active comparator | Not described Receives: Procedure: Early (24-72 hours) ruptured aneurysm clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate before anerysm clipping
The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed.
Measured: baseline, pre-surgery
Secondary outcomes (3)
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.
Measured: Up to 12 months after aneurysm surgery
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
Measured: Up to 3 weeks after aneurysm rupture
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.
Measured: Up to 12 months after aneurysm surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Revaz Dzhindzhikhadze
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Revaz Dzhindzhikhadze, Moscow Regional Research and Clinical Institute (MONIKI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457347
- Sponsor's protocol ID
- sah_moniki
- Status last verified
- Jun 2024
- First submitted
- 25 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21680909Tan 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.
PubMed 24848179Oudshoorn 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.
PubMed 24639201Dalbayrak 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.
PubMed 22368972Ross 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.
PubMed 11909907Dorhout 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.
PubMed 22700527
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Ultra Early Surgical Treatment of Ruptured Intracranial Aneurysms: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06457347
- Acronym / sponsor ID
- sah_moniki
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- aneurysm, subarachnoid hemorrhage, clipping, microsurgery, surgery timing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Revaz DzhindzhikhadzeOther government
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does ultra-early surgical intervention ( less than 24 hours of rupture) improve survival rates compared to delayed surgery (24 to 72 hours after rupture)?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aneurysmal subarachnoid hemorrhage
- patient eligible for surgical clipping
- patients with informed consent for inclusion into the study
Key exclusion criteria (3 listed)
- patients admitted and treated >72 h after subarachnoid hemorrhage onset
- patients with severe comorbidities
- patients with multiple aneurysms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra early (<24 hours) ruptured aneurysm clippingAneurysms are clipped with open surgery in less than 24 hours after rupture to prevent early rebleeding. | Procedure or surgery | Ultra early (<24 hours) |
| Early (24-72 hours) ruptured aneurysm clippingAneurysms are clipped with open surgery in 24 to 72 hours after rupture to prevent early rebleeding. | Procedure or surgery | Early (24-72 hours) |
Primary outcome
Rebleeding rate before anerysm clipping
Time frame: baseline, pre-surgery
The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed.
3 secondary outcomes
Clinical outcome according to the Modified Rankin Scale
Time frame: Up to 12 months after aneurysm surgery
Delayed cerebral ischemia
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 21680909Phillips 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.
- Background: PubMed 24848179Tan 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.
- Background: PubMed 24639201Oudshoorn 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.
- Background: PubMed 22368972Dalbayrak 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.
- Background: PubMed 11909907Ross 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.
- Background: PubMed 22700527Dorhout 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra early (<24 hours) ruptured aneurysm clipping and Early (24-72 hours) ruptured aneurysm clipping in people with Aneurysmal Subarachnoid Hemorrhage, run by Revaz Dzhindzhikhadze.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Revaz Dzhindzhikhadze, PhD (+79161519868, brainsurg77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rebleeding rate before anerysm clipping (time frame: baseline, pre-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06457347, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.