跳至主要内容
临床试验/NCT05116423
NCT05116423Unknown不适用

Personalized Machine-Learning Based Prediction Model for Bleeding in Immune Thrombocytopenia: a Nationwide Representative Data Study

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Performance of model

研究概览

简要总结

This study developed the first prediction model for risk of critical ITP bleeds for ITP inpatients using a novel machine learning algorithm. This model has been implemented as a web-based model so that clinicians can obtain the estimated probability of critical ITP bleeds for ITP inpatients. The objective of this study is to prospectively and externally validate the risk of critical ITP bleeds in newly admitted ITP patients.

详细描述

Primary immune thrombocytopenia (ITP) is a common acquired autoimmune disease characterized by reduced platelet production and increased platelet destruction due to autoimmune disorders, as patients present with low platelet counts and a high risk of bleeding. Although most ITP patients present a good prognosis, the rare but important critical ITP bleeds events are the threatening-life complication to ITP patients, severely affecting their prognosis, quality of life and treatment decisions.

More recently, the development of clinical prediction models has provided powerful tools for precision diagnosis and early intervention of diseases, especially the application of machine learning methods. Machine learning approaches can overcome some of the limitations of current risk prediction analysis methods by applying computer algorithms to large data sets with numerous multidimensional variables, capturing the high-dimensional nonlinear relationships between clinical features to produce data, drive outcome prediction.

It suggests an unmet need for personalized patient management strategies and an urgent need for effective tools to predict the risk of critical ITP bleeds in hospitalized patients in medical practice.

Here, we aim to integrate clinical and laboratory data based on a nationwide multicenter study in China to build a clinical prediction model. In particular, we also perform external and prospective validation with large sample sizes to improve the robustness and utility of our models.

It is a simple and convenient tool to quickly assess newly admitted ITP patients and achieve early identification and intervention for those at high risk of life-threatening bleeding events, thus reducing disability and mortality rates in the future.

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

  • Confirmed ITP diagnosis;

排除标准

  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
  • Current HIV infection or hepatitis B virus or hepatitis C virus infections;
  • Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
  • Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
  • Patients who are deemed unsuitable for the study by the investigator.

结局指标

主要结局

Performance of model

时间窗: 3 months

Area under receiver operating characteristic curve (AUC) of the model in predicting critical ITP bleeds in patients with ITP.

次要结局

  • Comparison between different machine learning algorithms used in the model(3 months)

研究者

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

Xiao Hui Zhang

Vice President of Peking University Institute of Hematology

Peking University People's Hospital

研究点 (1)

Loading locations...

相似试验