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

NCT ID: NCT05535309

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2023-12-30

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.

Conditions

Risk Factors

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Occurrence of coagulation disorder

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

cefoperazone sulbactam sodium

Intervention Type: DRUG

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

No coagulation disorder

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

cefoperazone sulbactam sodium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Li，MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiao Li,MD

Jinan, Shandong, China

Countries

China

Other Identifiers

LCYY-LX-20220105

Identifier Type: -

Identifier Source: org_study_id