Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra early (<24 hours) | Experimental |
| |
| Early (24-72 hours) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rebleeding rate before anerysm clipping | The rate of recurrent aneurysm rupture and subarachnoid hemorrhage before aneurysm surgery is performed. | baseline, pre-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Revaz Dzhindzhikhadze, PhD | Contact | +79161519868 | brainsurg77@gmail.com | |
| Vadim Gadzhiagaev, MD | Contact | +7-999-528-84-10 | vgadzhiagaev@yandex.ru |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21680909 | Background | 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. | |
| 24848179 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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 | 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. | Up to 12 months after aneurysm surgery |
| 24639201 | 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. |
| 22368972 | 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. |
| 11909907 | 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. |
| 22700527 | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |