Cerebral Aneurysms: a Retrospective Study on the Experience in Our Hospital With a Comparative Analysis Between the Different Techniques Used in Its Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- Cerebrospinal fluid diversion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •harbour one or more saccular brain aneurysms
- •with or without subarachnoid hemorrhage (SAH)
- •multiple aneurysms
排除标准
- •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
研究组 & 干预措施
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
干预措施: External ventricular drain (Procedure)
Embolization
These patients will be treated endovascularly
干预措施: Endovascular treatment (Procedure)
Programmed surgical clipping
These patients will be treated no on an emergency basis with surgical clipping of an aneurysm that has bled
干预措施: Clipping (Procedure)
Emergency surgical clipping with cisternal urokinase administration
These patients with undergo emergency surgical clipping with cisternal urokinase administration
干预措施: Urokinase (Drug)
Emergency surgical clipping with cisternal urokinase administration
These patients with undergo emergency surgical clipping with cisternal urokinase administration
干预措施: Clipping (Procedure)
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
干预措施: Clipping (Procedure)
结局指标
主要结局
Cerebrospinal fluid diversion
时间窗: 1 year
Need for temporary or definitive cerebrospinal fluid diversion
Vasospasm
时间窗: 21 days
Presence and severity of vasospasm
Mortality rate
时间窗: 1 year
Mortality rate in each group of patients
Outcome
时间窗: 1 year
Glasgow Outcome Score (GOSE) at discharge, 6 and 12 months posttreatment
次要结局
- Aneurysm rebleed(10 years)
- Aneurysm regrowth(10 years)
