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临床试验/NCT05525195
NCT05525195已完成不适用

Influence of Preoperative Fibrinogen Levels on Blood Loss and Transfusions in Pediatric Cardiac Surgery

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 932 人开始时间: 2022年9月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
932
试验地点
1
主要终点
Blood loss

研究概览

简要总结

Fibrinogen plays an important role in the coagulation cascade. Low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery. Guidelines from the European Society of Anesthesiology and Intensive Care recommends fibrinogen substitution based on viscoelastic tests in adult cardiac surgery. Cardiopulmonary bypass results in a profound hemodilution and dilution of all coagulation factors. This is especially true in children where the priming volume of the cardiopulmonary bypass circuit is much higher compared to the patient's weight than in adults. Cardiopulmonary bypass generates high levels of tissue plasminogen activator resulting in a hyperfibrinolysis, further lowering fibrinogen levels.

The aim of this retrospective study is to explore a possible relationship between preoperative fibrinogen levels and perioperative blood loss, as well as transfusion requirements in children undergoing cardiac surgery.

研究设计

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

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • all children with cardiac surgery under cardiopulmonary bypass between 2008 and 2018
  • Age < 16 year

排除标准

  • preoperative coagulopathy
  • Jehovah's witnesses
  • patients with fresh frozen plasma in the priming of the cardiopulmonary bypass circuit

结局指标

主要结局

Blood loss

时间窗: Day 0

Blood loss in mL during surgery and postoperatively during the first 24h (day 0) will be extracted from our database

Transfusion requirements

时间窗: Day 0

Transfusion requirements of packed red cells ( in mL), fresh frozen plasma (in mL) and platelets (in mL) during the first 24h (day 0) will be extracted from our database

次要结局

未报告次要终点

研究者

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

Denis SCHMARTZ

Head of department, anesthesiology

Brugmann University Hospital

研究点 (1)

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