Clinical Trials Directory

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UnknownNCT05116423

Machine-learning Based Prediction Model in Primary Immune Thrombocytopenia

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

Status
Unknown
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Peking University People's Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2021-11-10
Primary completion
2022-03-01
Completion
2022-06-30
First posted
2021-11-11
Last updated
2022-02-08

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05116423. Inclusion in this directory is not an endorsement.