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

Qianfoshan Hospital

Status: Completed

Conditions: Risk Factors

Treatments: Drug: cefoperazone sulbactam sodium

Study type: Observational

Funder types: Other

Identifiers

NCT05535309

LCYY-LX-20220105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,000 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

8,000 participants in 2 patient groups

Occurrence of coagulation disorder

Description:

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

Treatment:

Drug: cefoperazone sulbactam sodium

No coagulation disorder

Description:

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

Treatment:

Drug: cefoperazone sulbactam sodium