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Status unknownNCT05116423Updated Feb 8, 2022

Machine-learning Based Prediction Model in Primary Immune Thrombocytopenia

An observational study in Immune Thrombocytopenia and ITP, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Immune Thrombocytopenia
  • ITP

Keywords

  • Immune Thrombocytopenia
  • Prediction Model
03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 183 observational studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population included nonsplenectomized primary ITP inpatients 18 years of age or older. Patients who had a diagnosis of connective tissue disease, cancer (solid tumor or leukemia), or primary immune deficiency were excluded.

Inclusion criteria

  1. Confirmed ITP diagnosis;

Exclusion criteria

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
  2. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
  3. Maligancy;
  4. 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
  5. 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;
  6. Patients who are deemed unsuitable for the study by the investigator.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • ITP inpatients

    The study population included nonsplenectomized primary ITP inpatients 18 years of age or older. Patients who had a diagnosis of connective tissue disease, cancer (solid tumor or leukemia), or primary immune deficiency were excluded.

06

What researchers measure

Primary outcomes

  1. Performance of model

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

    Time frame: 3 months

Secondary outcomes

  1. Comparison between different machine learning algorithms used in the model

    Comparison of sensitivity and specificity of different machine learning algorithms used in the model.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Peking University Insititute of Hematology, Peking University People's Hospital
    Beijing, Beijing 100010, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05116423
Lead sponsor
Peking University People's Hospital
Collaborators
The Affiliated Zhongshan Hospital of Dalian University, Jiangsu Provincial People's Hospital, Qilu Hospital of Shandong University, Shanghai Zhongshan Hospital
Responsible party
Xiao Hui Zhang (Vice President of Peking University Institute of Hematology, Peking University People's Hospital) — Principal investigator
First posted
Nov 11, 2021
Start date
Nov 10, 2021
Primary completion
Mar 1, 2022 (estimated)
Completion
Jun 30, 2022 (estimated)
Last update
Feb 8, 2022

Study contacts

Xiao-Hui Zhang, MD
Contact
zhangxh100@sina.com
+8615010638916
Zhuo-Yu An, MD
Contact
anzhuoyu@pku.edu.cn
+8615010638916
Xiao-Hui Zhang, MD
principal investigator · Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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