跳至主要内容
临床试验/NCT04792944
NCT04792944已完成不适用

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

University of Valencia1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2007年1月1日最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Brain Aneurysms: Utility of Cisternal Urokinase... | 临床试验