Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Patient Reported Outcomes in Living Donor Lung Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Kyoto University, Graduate School of Medicine
Sponsor:
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: December 1, 2014
Last verified: December 2014
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Change in health status [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in dyspnea [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Change in psychological status [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Change in sleep quality [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
  • Prognosis [ Time Frame: At entry and every year for 5 years ] [ Designated as safety issue: No ]
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
Other Name: N.A.

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
Genders Eligible for Study:   Both
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

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

No publications provided

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: December 1, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by 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 February 27, 2015