跳至主要内容
临床试验/NCT04456751
NCT04456751已完成不适用

Is a Reintervention for Pediatric Cardiac Surgery Associated With Higher Blood Transfusion Requirements ?

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 2,439 人开始时间: 2020年7月2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
2,439
试验地点
1
主要终点
Transfusion of packed red cells (mL/kg)

研究概览

简要总结

In pediatric cardiac surgery, transfusion requirements are associated with age, development status, pathology, type of surgical intervention and extracorporeal bypass. In adult cardiac surgery, reinterventions (redo)are clearly linked to higher transfusion rates. The investigators want to study if this association is also true in pediatric cardiac surgery.

详细描述

Whereas in adult cardiac surgery, redo-interventions are clearly linked to a higher transfusion rate, this is not really known in paediatric cardiac surgery. In this retrospective study, the investigators will analyse our database for paediatric cardiac surgery patients aged 0-16 years and operated between 2002 and 2017. Patients with a single cardiac surgery will be compared to patients with a second cardiac operation under extracorporeal bypass. The investigators will test the variables for normal distribution using a Shapiro-Wilk test. Non normal distributed variables will be compared by a non-parametric test (Mann Whitney U), frequency analysis will be done by a Chi-Square test. A univariate analysis will determine predicting factors for transfusion. Factors with a P value < 0.1 will be analysed by a multivariate analysis to determine independent factors for transfusion. Odds with 95% confidence intervals will be calculated. A P value < 0.05 will be considered statistically significant.

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

  • Patients between 0 and 16 years
  • Cardiac surgery with cardiopulmonary bypass

排除标准

  • Jehova's witness

结局指标

主要结局

Transfusion of packed red cells (mL/kg)

时间窗: Day of operation up to 5 days postop

Transfusion requirements will be measured as volume of packed red cells given as mL packed red cells/kg of body weight

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 Anesthesiology department

Brugmann University Hospital

研究点 (1)

Loading locations...

相似试验