Immunosuppressants to Postoperative Infection and Death

Last updated: November 6, 2023
Sponsor: Chung Shan Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Organ Transplant

Treatment

Immunosuppressive Agents

Clinical Study ID

NCT06121804
CS2-21134
  • Ages > 20
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who underwent solid organ transplant (SOT)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 20000
Treatment Group(s): 1
Primary Treatment: Immunosuppressive Agents
Phase:
Study Start date:
December 20, 2021
Estimated Completion Date:
December 20, 2024

Study 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).

Connect with a study center

  • Chung Shan Medical University

    Taichung, 40201
    Taiwan

    Active - Recruiting

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