Immunosuppressants to Postoperative Infection and Death

Organ Transplantation Clinical Trial

Official title:

The Cost-effectiveness Analysis of Immunosuppressants to Postoperative Infection and Death in the Patients With Organ Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06121804
• Other study ID #: CS2-21134
• Status: Recruiting
• Start date: December 20, 2021
• Est. completion date: December 20, 2024

Study information

• Verified date: October 2023
• Source: Chung Shan Medical University
• Contact: Chien-Ying Lee, PhD
• Phone: 886-4-24730022
• Email: cshd015[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to explore the different immunosuppressive agents and related outcomes in organ transplantation patients in Taiwan. The main question it aims to answer is the risk of different immunosuppressive agents for infection and survival after transplant.

The study enrolled patients who underwent solid organ transplant (SOT), kidney (ICD-9-CM code V42.0), liver (ICD-9-CM code V42.7), or lung (ICD-9-CM code V42.6) transplants. We employed propensity score matching (PSM) to establish a matched cohort. The study will compare SOT patients and general patients to explore the risk of different immunosuppressive agents for infection and survival.

Description:

This study used secondary data from the Longitudinal Health Insurance Database (LHID), a subset of the NHIRD provided by the Health and Welfare Data Science Center (HWDC) of the Ministry of Health and Welfare in Taiwan.

The HWDC encrypts personally identifying data to protect the privacy of beneficiaries. The database includes detailed clinical records from both the inpatient and outpatient claims of the beneficiaries of Taiwan's National Health Insurance program. This program has provided coverage for up to 99% of the country's population since 1995. The NHIRD can serve as a foundation for the procurement of real-world evidence to support clinical decisions and health-care policy-making.

Diagnostic data within the NHIRD from before 2016 and from 2016 or later are respectively coded using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes.

The database was provided by the HWDC under license and so cannot be made freely available. Requests for access to these data should be made to HWDC (https://dep.mohw.gov.tw/dos/cp-5119-59201-113.html).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 20, 2024
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who underwent solid organ transplant (SOT)

Exclusion Criteria:

• Patients who received more than one SOT, had an infectious disease diagnosis before their SOT or had incomplete medical information in the database.

Related Conditions & MeSH terms

• Cohort Study
• Immunosuppressive Agents
• Infections
• Organ Transplantation

Intervention

Drug:
• Immunosuppressive Agents
Prescribing immunosuppressive agents

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative infection	Postoperative infection contains Pneumocystis jiroveci pneumonia, cytomegalovirus disease, and Herpes simplex virus	From the date of underwent SOTs until the date of incident infection or date of death from any cause, whichever came first, assessed up to 5 years.
Primary	Death	Death	From the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.

External Links

•   The Health and Welfare Data Science Center, Ministry of Health and Welfare Taiwan