Risk FactorsNCT05535309
Establishment of Risk Factors Model of Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium
An observational study of Risk Factors, run by Qianfoshan Hospital at 1 site in China.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Risk Factors
- What is being tested?
- cefoperazone sulbactam sodium
- Type of treatment
- Injection or infusion
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2021to 30 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All inpatients who used cefoperazone sulbactam sodium during hospitalization;
- Hospital stay ≥ 48h
- Age ≥ 18 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Risk Factors
- Being tested
- cefoperazone sulbactam sodium
- Keywords
- Coagulation disorder, Epidemiological study, Risk factors, Building models
- Medical subject headings
- Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cefoperazone sulbactam sodiumDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: cefoperazone sulbactam sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coagulation disorder
Coagulation disorder occurred after cefoperazone sulbactam sodium was used in the patient's hospitalization.
Measured: Through study completion,up to half a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start2 Nov 2021
- Primary completion30 May 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk FactorsStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 8,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Li，MD, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535309
- Sponsor's protocol ID
- LCYY-LX-20220105
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2022
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study on Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium and Construction of Prediction Model
- ClinicalTrials.gov ID
- NCT05535309
- Acronym / sponsor ID
- LCYY-LX-20220105
- Conditions
- Risk Factors
- Keywords
- Coagulation disorder, Epidemiological study, Risk factors, Building models
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occurrence of coagulation disorder | – | Drug: cefoperazone sulbactam sodium1. 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 |
| No coagulation disorder | – | Drug: cefoperazone sulbactam sodium1. 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- All inpatients who used cefoperazone sulbactam sodium during hospitalization;
- Hospital stay ≥ 48h
- Age ≥ 18 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cefoperazone sulbactam sodiumCefoperazone sodium and Sulbactam Sodium for injection (1; 1) are white or almost white powder drugs, and the components are cefoperazone sodium and sulbactam sodium | Drug | No coagulation disorder, Occurrence of coagulation disorder |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factors, run by Qianfoshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coagulation disorder (time frame: Through study completion,up to half a year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.