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临床试验/NCT03136536
NCT03136536Unknown不适用

Kärlkirurgi Vid Komplicerade kroppspulsåderbråck - Utfall, Riskfaktorer Och sökande Efter biomarkörer för Organskada

Region Örebro County1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Mortality

研究概览

简要总结

The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.

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

  • Accepted for endovascular advanced thoracoabdominal aortic surgical procedure

排除标准

  • 未提供

结局指标

主要结局

Mortality

时间窗: 1 year postoperative

Overall and aortic-related mortality

次要结局

  • Organ dysfunction and failure(Postoperative: 7 days, 30 days, 1 year follow-up)

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Sponsor

研究点 (1)

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