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Patient Reported Outcomes in Living Donor Lung Transplantation
This study is currently recruiting participants.
Verified September 2016 by Toru Oga, Kyoto University, Graduate School of Medicine
Sponsor:
Kyoto University, Graduate School of Medicine
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00905697
First received: May 18, 2009
Last updated: September 1, 2016
Last verified: September 2016
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Purpose
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 | Intervention |
|---|---|
| Lung Transplantation | Procedure: Living donor lung transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation |
Resource links provided by NLM:
Further study details as provided by Toru Oga, Kyoto University, Graduate School of Medicine:
Primary Outcome Measures:
- Change in health status [ Time Frame: At entry and every year for 5 years ]
Secondary Outcome Measures:
- Change in dyspnea [ Time Frame: At entry and every year for 5 years ]
- Change in psychological status [ Time Frame: At entry and every year for 5 years ]
- Change in sleep quality [ Time Frame: At entry and every year for 5 years ]
- Prognosis [ Time Frame: At entry and every year for 5 years ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Living donor lung transplantation
Living lung transplantation donors
|
Procedure: Living donor lung transplantation
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Kyoto University Hospital Clinic for Lung Transplantation
Criteria
Inclusion Criteria:
- New donors for living donor lung transplantation
Exclusion Criteria:
- Inability to obtain informed consent
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905697
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905697
Contacts
| Contact: Fengshi Chen, MD, PhD | +81 75 751 4975 | fengshic@kuhp.kyoto-u.ac.jp | |
| Contact: Toru Oga, MD, PhD | +81 75 751 3852 | ogato@kuhp.kyoto-u.ac.jp |
Locations
| Japan | |
| Graduate School of Medicine, Kyoto University | Recruiting |
| Kyoto, Japan | |
| Contact: Fengshi Chen, MD, PhD +81 75 751 4975 fengshic@kuhp.kyoto-u.ac.jp | |
| Contact: Toru Oga, MD, PhD +81 75 751 3852 ogato@kuhp.kyoto-u.ac.jp | |
| Sub-Investigator: Toru Bando, MD, PhD | |
| Sub-Investigator: Izumi Matsumoto | |
| Sub-Investigator: Hiroaki Sakai, MD | |
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 |
More Information
| Responsible Party: | Toru Oga, Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00905697 History of Changes |
| Other Study ID Numbers: |
E561kyoto |
| Study First Received: | May 18, 2009 |
| Last Updated: | September 1, 2016 |
Keywords provided by Toru Oga, Kyoto University, Graduate School of Medicine:
|
Living donor lung transplantation Health-related quality of life Prognosis Patient reported outcome |
ClinicalTrials.gov processed this record on August 21, 2017