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Risk Analysis of Cardiotoxic Medication Use Due to Sodium Arsenite Chloride Injection

NCT ID: NCT06060132

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-29

Study Completion Date

2023-12-31

Brief Summary

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To study the current status of cardiotoxicity of arsenious acid by analyzing the literature, monitoring data, and real-world applications, and to discuss risk factors and preventive and control measures.

Detailed Description

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Through the project study, the risk rate of cardiotoxicity caused by arsenious acid will be verified and evaluated, and a typical case analysis will be conducted to assess the risk and benefit ratio of clinical use of arsenious acid injection and to formulate preventive measures, so as to guide the holder of the marketing authorization to carry out in-depth safety studies and to ensure the public's safe use of the drug.

Conditions

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Adverse Reaction Cardiotoxicity Evaluation Study

Keywords

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arsenious acid arsenic trioxide cardiotoxicity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Sodium arsenite chloride injection

Patient use of arsenite sodium chloride injection

Intervention Type DRUG

Other Intervention Names

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arsenic trioxide

Eligibility Criteria

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Inclusion Criteria

* the period of consultation (for inpatients, according to the time of admission) is from January 1, 2012 to December 31, 2022
* the patient used arsenite sodium chloride injection

Exclusion Criteria

* Patients with incomplete clinical information
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qianfoshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yi Han

Associate professor of pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Han, doctorate

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital

Locations

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China

Jinan, Shandong, China

Site Status RECRUITING

First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Han, doctorate

Role: CONTACT

Phone: 15552565120

Email: [email protected]

Facility Contacts

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Yi Han, doctorate

Role: primary

Yi Han, doctorate

Role: primary

Other Identifiers

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YSS001

Identifier Type: -

Identifier Source: org_study_id