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

NCT05535309 | Completed

• 1 other identifier: LCYY-LX-20220105
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Factors

Keywords

Coagulation disorder; Epidemiological study; Risk factors; Building models

Outcome Measures

Primary Outcomes (1)

• Coagulation disorder

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

  Through study completion,up to half a year.

Study Arms (2)

Occurrence of coagulation disorder

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

Drug: cefoperazone sulbactam sodium

No coagulation disorder

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

Drug: cefoperazone sulbactam sodium

Interventions

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

No coagulation disorder; Occurrence of coagulation disorder

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• All inpatients who used cefoperazone sulbactam sodium during hospitalization;
• Hospital stay ≥ 48h
• Age ≥ 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Xiao Li,MD

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: November 2, 2021
• Primary Completion: May 30, 2023
• Study Completion: December 30, 2023
• Last Updated: April 3, 2024

Record last verified: 2023-11

Locations

CN (1)