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

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.

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Key information

Conditions

Risk Factors Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiao Li,MD

Jinan, Shandong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cefoperazone sulbactam sodium

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

Primary outcomes

Coagulation disorder

Time frame: Through study completion,up to half a year.

Coagulation disorder occurred after cefoperazone sulbactam sodium was used in the patient's hospitalization.

Sponsors and collaborators

Lead sponsor

Qianfoshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Sep 10, 2022
Registry last updated: Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed