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临床试验/NCT05466370
NCT05466370已完成不适用

Prediction of Transfusion-Associated Complications

Kepler University Hospital1 个研究点 分布在 1 个国家目标入组 3,366 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,366
试验地点
1
主要终点
AUROC for Classification of AKI

研究概览

简要总结

Currently, about 350000 red blood cell concentrates are produced from blood donations in Austria every year.

In addition to the main effect of replacing lost blood, red blood cell concentrates also have many undesirable effects - from blood group compatibilities, which are easily avoidable due to care, to storage-related side effects, to mostly intensive care problems as a result of massive transfusions, to system-wide effects such as TRALI, TACO and TRIM.

Before being administered to patients, red blood cell concentrates undergo an extensive quality assurance process in which a large number of parameters are collected. Prior to use on patients, for example, bedside tests and tests for further incompatibilities with a blood sample from the intended patient are performed. With the implementation of Patient Blood Management (PBM) in recent years, the use of red cell concentrates has become more targeted - the number of transfusions is decreasing in most developed countries. However, it is still possible to suffer transfusion-related adverse events (TRAE). Thus, active research activity to reduce these TRAEs continues to be called for.

To date, however, it is not known which patients experience transfusion-related adverse events. Despite the broad measures of hemovigilance and pre-transfusion testing, it is still not possible to predict which individual patient will respond to a transfusion with a typical adverse event such as hypotension, hemolysis, renal failure, or TRALI. It seems understandable that characteristics of the patient as well as characteristics of the administered unit could play a role for this. In particular, it is conceivable that a combination of characteristics of the blood unit and characteristics of the patient could determine a complication in the course of administration. For this reason, it seems attractive to use artificial intelligence and machine learning methods to predict any complications.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients that received at a blood transfusion the Kepler University Hospital in the period between 2016-10-31 to 2020-08-31.

排除标准

  • 未提供

结局指标

主要结局

AUROC for Classification of AKI

时间窗: 2016-10-31 to 2020-08-31

AUROC for Classification of AKI

AUROC for Classification of AKI and ARF

时间窗: 2016-10-31 to 2020-08-31

AUROC for Classification of AKI and ARF

AUROC for Classification of ARF

时间窗: 2016-10-31 to 2020-08-31

AUROC for Classification of ARF

次要结局

  • Confusion Matrix(2016-10-31 to 2020-08-31)
  • Descriptive Statistics(2016-10-31 to 2020-08-31)

研究者

发起方
Kepler University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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