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NCT00905697 Clinical Trial

Patient Reported Outcomes in Living Donor Lung Transplantation

Lung Transplantation Clinical Trial

Official title:
Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00905697
Other study ID # E561kyoto
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2009
Est. completion date August 2019

Study information
Verified date August 2019
Source Kyoto University, Graduate School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.

Description:

In Japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. However, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. Therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- New donors for living donor lung transplantation

Exclusion Criteria:

- Inability to obtain informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Living donor lung transplantation
Living donor lung transplantation

Locations
Country Name City State
Japan Graduate School of Medicine, Kyoto University Kyoto

Sponsors (2)
Lead Sponsor Collaborator
Kyoto University, Graduate School of Medicine Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in health status At entry and every year for 5 years
Secondary Change in dyspnea At entry and every year for 5 years
Secondary Change in psychological status At entry and every year for 5 years
Secondary Change in sleep quality At entry and every year for 5 years
Secondary Prognosis At entry and every year for 5 years
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