Patient Reported Outcomes in Living Donor Lung Transplantation

• Sponsor: Kyoto University, Graduate School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00905697
• Collaborator: Ministry of Health, Labour and Welfare, Japan (Other)
• Enrollment: 40
• Location: 1
• Duration (Months): 124
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplantation	Procedure: Living donor lung transplantation

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Aug 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Living donor lung transplantation Living lung transplantation donors	Procedure: Living donor lung transplantation; Living donor lung transplantation

Outcome Measures

Primary Outcome Measures

1. Change in health status [At entry and every year for 5 years]

Secondary Outcome Measures

1. Change in dyspnea [At entry and every year for 5 years]

2. Change in psychological status [At entry and every year for 5 years]

3. Change in sleep quality [At entry and every year for 5 years]

4. Prognosis [At entry and every year for 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• New donors for living donor lung transplantation

Exclusion Criteria:

• Inability to obtain informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Graduate School of Medicine, Kyoto University	Kyoto		Japan

Sponsors and Collaborators

• Kyoto University, Graduate School of Medicine
• Ministry of Health, Labour and Welfare, Japan

Investigators

• Study Chair: Hiroshi Date, MD, PhD, Graduate School of Medicine, Kyoto University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Toru Oga, Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine
• ClinicalTrials.gov Identifier: NCT00905697
• Other Study ID Numbers: E561kyoto
• First Posted: May 20, 2009
• Last Update Posted: Aug 28, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Toru Oga, Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine: Living donor lung transplantation; Health-related quality of life; Prognosis; Patient reported outcome

Study Results

No Results Posted as of Aug 28, 2019