Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction

Blood Coagulation Disorder Clinical Trial

Official title:

Biomarkers and Prediction of Tigecycline Induced Coagulation Dysfunction Based on Multi-omics and Machine Learning Techbology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05698160
• Other study ID #: 2022-LCYJ-PY-14
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is to screen out the biomarkers and establish the model to predict coagulation dysfunction induced tigecycline

Description:

The critically ill patients treated with tigecycline in in tensive care unit will be recruited and divided into tigecycline-induced coagulation dysfunction group and non-coagulation dysfunction group. The multi-omics will be used to screen out biomarkers for early prediction of coagulation dysfunction caused by tigecycline. Afterwards, machine learning methods will be adopted to establish the the early prediction model of tigecycline-induced coagulation dysfunction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatients receiving tigecycline treatment in the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

• Intravenous tigecycline = 3 days

• Monitoring the plasma concentration of tigecycline

Exclusion Criteria:

• Missing clinical data

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers associated with the coagulation dysfunction induced tigecycline	Multi-omics will be adopted to screen out biomarkers associated with the coagulation dysfunction induced by tigecycline.	January 2023-December 2025
Secondary	Prediction model for coagulation dysfunction induced by tigecycline	Machine learning techbology will be adopted to establish the prediction model for coagulation dysfunction induced by tigecycline	January 2023-December 2025