Establishment of Risk Factors Model of Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium

Risk Factors Clinical Trial

Official title:

Epidemiological Study on Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium and Construction of Prediction Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535309
• Other study ID #: LCYY-LX-20220105
• Status: Completed
• Start date: November 2, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The incidence rate of drug-induced blood diseases accounts for about 10% of all drug-induced diseases, most of which are serious at the time of onset, and the mortality rate can be as high as 32.5%. In this study, cefoperazone sulbactam sodium, which is commonly used in clinic, was selected as the target drug, and the epidemiological characteristics of drug-induced coagulation dysfunction and the construction of risk factor models were studied by single factor and multiple factor Logistic regression analysis.

Description:

Investigators selected inpatients from Qianfoshan Hospital of Shandong Province from January 1, 2018 to December 30, 2021, extracted the cohort according to the inclusion and exclusion criteria, and divided it into exposure group and control group to find out the risk factors of cefoperazone sulbactam sodium causing coagulation disorders, and build a risk factor model of drug-induced coagulation disorders caused by cefoperazone sulbactam sodium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: December 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

All inpatients who used cefoperazone sulbactam sodium during hospitalization;

• Hospital stay = 48h
• Age = 18 years old

Exclusion Criteria:

• Age < 18 years
• Severe liver and kidney dysfunction
• Patients with vitamin K deficiency
• Patients with hematological diseases
• Patients with advanced malignant tumor or mental disease
• Patients with incomplete clinical data

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Risk Factors

Intervention

Drug:
• cefoperazone sulbactam sodium
Cefoperazone sodium and Sulbactam Sodium for injection (1; 1) are white or almost white powder drugs, and the components are cefoperazone sodium and sulbactam sodium

Locations

Country	Name	City	State
China	Xiao Li,MD	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coagulation disorder	Coagulation disorder occurred after cefoperazone sulbactam sodium was used in the patient's hospitalization.	Through study completion,up to half a year.