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临床试验/NCT03604276
NCT03604276进行中(未招募)不适用

Neuroinflammatory Response and Headache Control in Patients After Subarachnoid Hemorrhage (HASH4-CSF) - An Observational Trial

MaineHealth1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
MaineHealth
入组人数
60
试验地点
1
主要终点
Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH.

研究概览

简要总结

The purpose of this study is to determine the relationship between the Neuroinflammatory response and headache pain after subarachnoid hemorrhage.

详细描述

Persistent headache is a significant medical issue that affects 20% of patients who survive an aneurysmal subarachnoid hemorrhage (SAH). This headache may last years, severely affecting quality of life. Laboratory evidence suggests that the persistent headache may be a result of a maladaptive neuroinflammatory response to the hemorrhage injury that is more vigorous than necessary. The goal of this study is to measure key immunomodulators in the blood and the cerebrospinal fluid of these patients in order to determine the magnitude and dynamics of their neuroinflammatory response. In addition, the investigators will collect and analyze observational data about the success of medications to treat headache, with a specific focus on the anti-inflammatory agent dexamethasone, in managing acute headache pain and preventing the development of persistent headaches in patients after SAH.

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

  • Non-traumatic subarachnoid hemorrhage
  • Age > 18 years
  • Treated with external ventricular drainage

排除标准

  • Pregnancy or lactation
  • Age < 18 years
  • Traumatic SAH

结局指标

主要结局

Characterization of the neuroinflammatory response in the CSF and blood of patients with non-traumatic SAH.

时间窗: 10 days

Determination of correlation between the neuroinflammatory response and development of chronic headache.

时间窗: 1 year

Determination of correlation between the neuroinflammatory response and severity/presence of headache pain.

时间窗: 10 days

次要结局

  • Comparison of the neuroinflammatory response in the CSF and blood in patients treated with dexamethasone versus other analgesics post SAH.(10 days)
  • Comparison of dexamethasone versus other analgesics in their ability to improve measures of quality of life.(1 year)

研究者

发起方
MaineHealth
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Glisic

Clinical Pharmacist

MaineHealth

研究点 (1)

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