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

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.

Study Overview

• Status: Completed
• Conditions: Risk Factors
• Intervention / Treatment: Drug: cefoperazone sulbactam sodium

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.

• Study Type: Observational
• Enrollment (Actual): 8000

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Xiao Li,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Investigators included inpatients who were hospitalized from January 1, 2018 to December 30, 2021. The patients must be over 18 years old and take cefoperazone sulbactam sodium. Patients with underlying diseases that may affect the results were excluded and divided into exposure group and control group for study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Occurrence of coagulation disorder; All inpatients who used cefoperazone sulbactam sodium during hospitalization；; Hospital stay ≥ 48h;; Age ≥ 18 years old;; Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and platelet (PLT) were detected twice or more during hospitalization	Drug: 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
No coagulation disorder; Inpatients who did not use cefoperazone sulbactam sodium during hospitalization;; Hospital stay ≥ 48h;; Age ≥ 18 years old;; Prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and platelet (PLT) were detected twice or more during hospitalization	Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Epidemiological study; Risk factors; Coagulation disorder; Building models
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Anti-Infective Agents, Urinary; Sulbactam; Cefoperazone; Sulperazone
• Other Study ID Numbers: LCYY-LX-20220105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No