An observational study in Risk Factors, sponsored by Qianfoshan Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Qianfoshan Hospital · Observational
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.
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.
515 studies on the registry are indexed under Hemostatic Disorders; 72 are open to participants now.
This study's enrollment of 8,000 is above the median of 100 across 233 observational studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Qianfoshan Hospital is the lead sponsor of 143 studies on the registry; 74 are open to participants now.
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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.
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All inpatients who used cefoperazone sulbactam sodium during hospitalization;
Exclusion Criteria:
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
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
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
Coagulation disorder
Coagulation disorder occurred after cefoperazone sulbactam sodium was used in the patient's hospitalization.
Time frame: Through study completion,up to half a year.
Ran from Nov 2021 to primary completion in May 2023, 18 months.
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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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