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Immunosuppressants to Postoperative Infection and Death

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06121804
Enrollment
20000
Registered
2023-11-08
Start date
2021-12-20
Completion date
2024-12-20
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cohort Study, Immunosuppressive Agents, Organ Transplantation

Brief 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.

Detailed 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).

Interventions

DRUGImmunosuppressive Agents

Prescribing immunosuppressive agents

Sponsors

Chung Shan Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative infectionFrom 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.Postoperative infection contains Pneumocystis jiroveci pneumonia, cytomegalovirus disease, and Herpes simplex virus
DeathFrom the date of underwent SOTs until the date of death from any cause, assessed up to 5 years.Death

Countries

Taiwan

Contacts

Primary ContactChien-Ying Lee, PhD
cshd015@csmu.edu.tw886-4-24730022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026