Brain Aneurysms: Utility of Cisternal Urokinase Irrigation
NCT ID: NCT04792944
Last Updated: 2021-03-11
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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COMPLETED
247 participants
OBSERVATIONAL
2007-01-01
2020-12-31
Brief Summary
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Although embolization prevents aneurysm' rebleeding, it does remove the subarachnoid blood clot. Therefore, it does not modify the evolution, incidence and severity of vasospasm.
The idea is to carry out a 10-year retrospective study classifying patients into five groups based on the type of treatment received, analyzing the results' differences. The aim is to improve what is done as much as possible and to be able to propose potential areas for improvement. Besides, this study will be the basis of a future prospective study, prepared without the current one's biases and errors.
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Detailed Description
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Stabilizing the aneurysm by embolization or surgical clipping leaves unresolved the vasospasm, responsible for ischemic brain damage, causing neurological sequelae and cognitive impairment.
It has long been known that the deoxyhemoglobin liberated from the extravasated red blood cells retained in the subarachnoid clot is the leading cause of vasospasm. Different routes have been tried to minimize its deleterious effects, such as copious lavage of the skull base cisterns, lysing the subarachnoid clot with urokinase or rtPA, administration of vitamin C, iron chelators, or superoxydodismutase-like drugs.
The volume of subarachnoid hemorrhage was soon correlated with the vasospasm severity. Once this fact was known in the 1980s and 1990s, cisternal lavage was used extensively during aneurysms' surgical clipping. Clots located in the subarachnoid space were lysed with urokinase or rtPA (recombinant tissue plasminogen activator), showing positive effects, particularly evident for the most severe bleeds, those with Fisher's grades of 3 or higher.
However, the introduction of embolization changed the treatment paradigm. As the craniotomy is not carried out, the cisterns are not usually washed, which controls the rebleeding but not the vasospasm. To date, we are not aware of any study that compares the effect on vasospasm of embolization versus clipping of aneurysms with lavage of the cisterns using thrombolytic agents.
In the Neurosurgery Department of our Hospital, two periods can be identified in which the treatment of brain aneurysms has been carried out differently. In the first period between 2007 and 2011, the aneurysms were primarily subjected to embolization, and only if there was no indication for endovascular treatment, surgical clipping was performed. In the second period, between 2012 and 2018, they were operated on an emergency basis with clip application and the skull base cisterns washed with urokinase. Embolization was considered if the surgical clipping was judged too risky.
The aim is to analyze these two periods and compare the mortality, morbidity, and vasospasm rates, the need for a cerebrospinal fluid diversion (temporary and definitive), and the final neurological and cognitive status for the different therapeutic approaches.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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No treatment
Those are the patients that do not receive any treatment for the aneurysm, neither endovascular nor surgical
No interventions assigned to this group
External ventricular drain only with neither embolization nor clipping
These patients will be treated with an external ventricular drain only with neither embolization nor clipping
External ventricular drain
Insertion of an external ventricular drain to treat acute hydrocephalus
Embolization
These patients will be treated endovascularly
Endovascular treatment
Aneurysm treatment through endovascular methods
Programmed surgical clipping
These patients will be treated no on an emergency basis with surgical clipping of an aneurysm that has bled
Clipping
Surgical clipping of brain aneurysms
Emergency surgical clipping with cisternal urokinase administration
These patients with undergo emergency surgical clipping with cisternal urokinase administration
Urokinase
Washing the subarachnoid clot induced by a subarachnoid haemorrhage aneurysmal bleeding with urokinase after aneurysm clipping
Clipping
Surgical clipping of brain aneurysms
Patients with incidental brain aneurysm discovery with no SAH and programmed aneurysm clipping
This group will include patients with incidental brain aneurysm discovery with no SAH and programmed aneurysm clipping
Clipping
Surgical clipping of brain aneurysms
Interventions
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Urokinase
Washing the subarachnoid clot induced by a subarachnoid haemorrhage aneurysmal bleeding with urokinase after aneurysm clipping
Endovascular treatment
Aneurysm treatment through endovascular methods
Clipping
Surgical clipping of brain aneurysms
External ventricular drain
Insertion of an external ventricular drain to treat acute hydrocephalus
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* harbour one or more saccular brain aneurysms
* with or without subarachnoid hemorrhage (SAH)
* multiple aneurysms
Exclusion Criteria
* SAH due to other causes (trauma, anticoagulation, antiplatelet medication, arteriovenous malformation, or tumor)
* any medical, neurological, or psychiatric condition that would impair patient's evaluation
* past medical history of bleeding disorders or liver diseases altering the coagulation
* anticoagulation
* platelet count \<10x109/L
* prothrombin time \>15 seconds
18 Years
ALL
No
Sponsors
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University of Valencia
OTHER
Responsible Party
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Principal Investigators
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Teresa V Moratal, Nurse
Role: STUDY_CHAIR
Hospital General Universitario Valencia
Locations
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Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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References
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Arakawa Y, Kikuta K, Hojo M, Goto Y, Yamagata S, Nozaki K, Hashimoto N. Milrinone reduces cerebral vasospasm after subarachnoid hemorrhage of WFNS grade IV or V. Neurol Med Chir (Tokyo). 2004 Aug;44(8):393-400; discussion 401. doi: 10.2176/nmc.44.393.
Arthur AS, Fergus AH, Lanzino G, Mathys J, Kassell NF, Lee KS. Systemic administration of the iron chelator deferiprone attenuates subarachnoid hemorrhage-induced cerebral vasospasm in the rabbit. Neurosurgery. 1997 Dec;41(6):1385-91; discussion 1391-2. doi: 10.1097/00006123-199712000-00028.
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Other Identifiers
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CEIm 17-07-2019
Identifier Type: -
Identifier Source: org_study_id
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