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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:
ClinicalTrials.gov Identifier:
NCT00905697
First Posted: May 20, 2009
Last Update Posted: September 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
  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 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: May 18, 2009
First Posted: May 20, 2009
Last Update Posted: September 2, 2016
Last Verified: September 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