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临床试验/NCT02605330
NCT02605330已完成不适用

Kinetics of Plasma Fibrinogen During Cardiac and Thoracic Aortic Surgery

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Plasma fibrinogen concentration

研究概览

简要总结

The study intends to measure fibrinogen plasma levels during the first 24 hrs in cardiac and thoracic surgical patients who undergo surgical procedures using extracorporeal circulation.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective patients undergoing coronary artery bypass grafting, aortic valve replacement or thoracic aortic surgery
  • Signed written informed consent

排除标准

  • Participation in another study
  • Language barrier to understand study purposes (e.g. french as a native language)
  • Preoperative low level of plasma fibrinogen (< 1.75 g/l)
  • Preoperative anemia (Hb < 10g/dl)
  • Emergency treatment
  • Intake of anticoagulants other than aspirin within 14 days preceding surgery.
  • Known coagulation disorder.
  • Jehovah's witnesses

结局指标

主要结局

Plasma fibrinogen concentration

时间窗: through study completion, an average of 1 year

Conventional (Clauss) and thromboelastometric measurement (FIBTEM)

次要结局

  • Periprocedural thromboembolic complications(through study completion, an average of 1 year)
  • In-hospital mortality(through study completion, an average of 1 year)
  • Platelet count(through study completion, an average of 1 year)
  • Prothrombin time (Quick)(through study completion, an average of 1 year)
  • Thoracic drain loss(through study completion, an average of 1 year)
  • Intensive Care Unit (ICU) length of stay(through study completion, an average of 1 year)
  • Thrombin concentration(through study completion, an average of 1 year)
  • Activated partial thromboplastin time (aPTT)(through study completion, an average of 1 year)
  • Thromboelastometric (ROTEM) parameters (e.g., INTEM, EXTEM, HEPTEM)(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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