临床试验/NCT03452722

NCT03452722已完成不适用

Neuroinflammatory Response in Patients With ICH and IVH Treated With rtPA

University of Rijeka0 个研究点目标入组 88 人开始时间: 2011年6月1日最近更新: 2019年3月26日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Rijeka
入组人数: 88
主要终点: Cytokine concentration difference between two groups

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study compares the neuroinflammatory response in patients with hypertensive ICH associated with IVH treated with intraventriculary applied rtPA, and the control group. The inflammatory mediator concentration is analyzed in local cerebrospinal liquor.

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subjects with primary ICH with IVH
•ICH score 2-4, , with origin of the hematoma in the basal ganglia and blood in the third and/or ventricle
•Patient is not considered a surgical candidate by neurosurgery service

排除标准

•No history of diseases or drugs that affect the immunological system.
•ICH score 1 and 5
•Current participation in another research drug treatment protocol
•Previously known intracranial arteriovenous malformation or aneurysms
•Intracerebral hematoma considered to be related to trauma
•ICH is located in the pons
•Blood in the subarachnoid space visualized on CT scan

研究组 & 干预措施

Study group

Applied rtPA

干预措施: intraventricual recombinant tissue plasminogen activator application (Drug)

结局指标

主要结局

Cytokine concentration difference between two groups

时间窗: Samples taken on day 0, day 1, day 3 and day 7.

Cytokine concentration measured from CSL

次要结局

未报告次要终点

研究者

发起方

University of Rijeka

申办方类型

Other

责任方

Principal Investigator

主要研究者

Matija Sošić

University of Rijeka

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