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临床试验/NCT03738644
NCT03738644已完成不适用

Near-infrared Spectroscopy in Endovascular Treatment (Danish: Nær-infrarød Spektroskopi Ved endovaskulær Trombektomi)

Helle Klingenberg Iversen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Oxygenated hemoglobin ratio of total hemoglobin before, during and after endovascular treatment

研究概览

简要总结

The purpose of this study is to examine the hemodynamics of stroke patients with near-infrared spectroscopy before, during and after endovascular treatment and their relations to disabilities and mortality 3 months after treatment.

详细描述

Endovascular treatment is the revascularization after ischemic stroke due to large-artery occlusion by mechanical removal of thrombi with an intraarterial catheter. The area around the infarction called the penumbra, which has partial blood supply by collateral vessels, can thereby be salvaged and the neuronal function restored. EVT lowers the disabilities and the morbidity if it is performed within 6 hours of onset or within 24 hours in stroke patients with a significant penumbra (Rodrigues, Neves et al. 2016).

However, complications can arise during EVT including critically failing CBF, intracranial hemorrhage and embolization of the thrombus to more peripheral vessels, which can all result in further brain damage.

To avoid these repercussions or detect them as fast as possible as well as detecting successful interventions, a suitable method for monitoring CBF over time is needed. NIRS is a commonly applied method that examines CBF in the cerebral cortex, which has already been used as intraoperative monitoring during abdominal and cardiac surgery (Yu, Zhang et al. 2018), but only in minor studies of EVT patients, where results have been very promising and associated to long-term outcomes (Hametner, Stanarcevic et al. 2015, Ritzenthaler, Cho et al. 2017). NIRS exploits that absorption of infrared light is only changed by hemoglobin, which can therefore by measured over time. NIRS is a non-invasive and safe method that measures oxygenated and deoxygenated hemoglobin in the cerebral cortex (Ferrari and Quaresima 2012).

Cerebral autoregulation (CA) is a complex mechanism that maintains an relatively constant and adequate CBF, which is often impaired in acute stroke patients (Paulson, Strandgaard et al. 1990). The nature of CA can be examined with NIRS (Obrig, Neufang et al. 2000, Reinhard, Wehrle-Wieland et al. 2006, Schytz, Hansson et al. 2010, Zweifel, Dias et al. 2014) and impairment can be shown (Li, Wang et al. 2010, Han, Li et al. 2014, Han, Zhang et al. 2014, Phillip and Schytz 2014). NIRS examinations of CA has never been done during EVT and the relation between changes in CA and patient outcome remains unknown.

This leads to the following hypothesis:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Stroke patients receiving endovascular treatment

排除标准

  • Premorbid mRS > 3
  • Acute EEG examinations within 2 hours after EVT
  • Neurosurgical evacuation within 2 hours after EVT
  • Remaining life expectancy < 90 days

结局指标

主要结局

Oxygenated hemoglobin ratio of total hemoglobin before, during and after endovascular treatment

时间窗: From onset of examination before EVT, during EVT and up to 2 hours after EVT.

Variability in oxygenated hemoglobin from onset of examination before EVT until end of examination up to 2 hours after EVT

次要结局

未报告次要终点

研究者

发起方
Helle Klingenberg Iversen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Helle Klingenberg Iversen

Senior neurologist, Head of Stroke Unit, Associate Professor

Rigshospitalet, Denmark

研究点 (1)

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