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Brain Aneurysms: Utility of Cisternal Urokinase Irrigation

Cerebral Aneurysms: a Retrospective Study on the Experience in Our Hospital With a Comparative Analysis Between the Different Techniques Used in Its Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04792944
Acronym
BA&UK
Enrollment
247
Registered
2021-03-11
Start date
2007-01-01
Completion date
2020-12-31
Last updated
2021-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage, Aneurysmal, Vasospasm, Cerebral, Hydrocephalus

Keywords

Aneurysm, Subarachnoid haemorrhage, Fibrinolytic Therapy, Intracisternal fibrinolysis, Cerebral vasospasm, Delayed ischemic neurological deficit

Brief summary

Despite the efforts made in its treatment, aneurysmal subarachnoid haemorrhage continues to induce high mortality and morbidity rates. Today there are treatment protocols in all hospitals. The vast majority prefer, whenever possible, the endovascular route, given its lesser aggressiveness and morbidity. 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.

Detailed description

Aneurysmal subarachnoid hemorrhage continues to have very high morbidity and mortality rates, despite the years elapsed and repeated attempts to reduce it. 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.

Interventions

Washing the subarachnoid clot induced by a subarachnoid haemorrhage aneurysmal bleeding with urokinase after aneurysm clipping

PROCEDUREEndovascular treatment

Aneurysm treatment through endovascular methods

PROCEDUREClipping

Surgical clipping of brain aneurysms

Insertion of an external ventricular drain to treat acute hydrocephalus

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \>18 years of age * harbour one or more saccular brain aneurysms * with or without subarachnoid hemorrhage (SAH) * multiple aneurysms

Exclusion criteria

* absence of brain fusiform, traumatic or mycotic aneurysms * 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

Design outcomes

Primary

MeasureTime frameDescription
Vasospasm21 daysPresence and severity of vasospasm
Cerebrospinal fluid diversion1 yearNeed for temporary or definitive cerebrospinal fluid diversion
Mortality rate1 yearMortality rate in each group of patients
Outcome1 yearGlasgow Outcome Score (GOSE) at discharge, 6 and 12 months posttreatment

Secondary

MeasureTime frameDescription
Aneurysm regrowth10 yearsAneurysm regrowth on follow-up after each tipe of treatment
Aneurysm rebleed10 yearsAneurysm rebleed on follow-up after each tipe of treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026