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

Completed

• Conditions: Risk Factors
• Interventions: Drug: cefoperazone sulbactam sodium

• Registration Number: NCT05535309
• Lead Sponsor: Qianfoshan Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-11-02
• Study First Submitted: 2022-09-06
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-10
• Primary Completion: 2023-05-30
• Status Verified: 2023-11
• Study Completion: 2023-12-30
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No coagulation disorder	cefoperazone sulbactam sodium	1. Inpatients who did not use cefoperazone sulbactam sodium during hospitalization; 2. Hospital stay ≥ 48h; 3. Age ≥ 18 years old; 4. Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and platelet (PLT) were detected twice or more during hospitalization
Occurrence of coagulation disorder	cefoperazone sulbactam sodium	1. All inpatients who used cefoperazone sulbactam sodium during hospitalization； 2. Hospital stay ≥ 48h; 3. Age ≥ 18 years old; 4. Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and platelet (PLT) were detected twice or more during hospitalization

Primary Outcome Measures

Name	Time	Method
Coagulation disorder	Through study completion,up to half a year.	Coagulation disorder occurred after cefoperazone sulbactam sodium was used in the patient's hospitalization.

Trial Locations

Locations (1)

Xiao Li,MD; 🇨🇳 Jinan, Shandong, China