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Clinical trial

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

ID
Name
LCYY-LX-20220105
Description
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.
Trial arms
Trial start
2021-11-02
Estimated PCD
2023-05-30
Trial end
2023-12-30
Status
Completed
Treatment
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
Arms:
No coagulation disorder, Occurrence of coagulation disorder
Size
8000
Primary endpoint
Coagulation disorder
Through study completion,up to half a year.
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 8000, 'type': 'ACTUAL'}}
Updated at
2024-04-03

1 organization

1 product

1 indication

Organization
Qianfoshan Hospital
Product
Cefoperazone Sulbactam
Indication
Risk Factors