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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05535309

Enrollment

8000

Registered

2022-09-10

Start date

2021-11-02

Completion date

2023-12-30

Last updated

2024-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Risk Factors

Keywords

Coagulation disorder, Epidemiological study, Risk factors, Building models

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.

Interventions

DRUGcefoperazone 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

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026