Aneurysmal Subarachnoid Hemorrhage
Conditions
Keywords
aneurysm, subarachnoid hemorrhage, clipping, microsurgery, surgery timing
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: 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.
Interventions
PROCEDUREUltra early (<24 hours) ruptured aneurysm clipping
Aneurysms are clipped with open surgery in less than 24 hours after rupture to prevent early rebleeding.
PROCEDUREEarly (24-72 hours) ruptured aneurysm clipping
Aneurysms are clipped with open surgery in 24 to 72 hours after rupture to prevent early rebleeding.
Sponsors
Revaz Dzhindzhikhadze
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding rate before anerysm clipping | baseline, pre-surgery | The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome according to the Modified Rankin Scale | 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. |
| Delayed cerebral ischemia | 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 |
| Rate of occlusion according to modified Raymond-Roy classification | 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. |
Contacts
Primary ContactRevaz Dzhindzhikhadze, PhD
Backup ContactVadim Gadzhiagaev, MD
Outcome results
None listed