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Trial record 2 of 77 for:    "Living Donors" | Recruiting, Not yet recruiting, Available Studies

Patient Reported Outcomes in Living Donor Lung Transplantation

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ClinicalTrials.gov Identifier: NCT00905697
Recruitment Status : Recruiting
First Posted : May 20, 2009
Last Update Posted : September 2, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
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
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation
Study Start Date : April 2009
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort 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 [ Time Frame: At entry and every year for 5 years ]

Secondary Outcome Measures :
  1. Change in dyspnea [ Time Frame: At entry and every year for 5 years ]
  2. Change in psychological status [ Time Frame: At entry and every year for 5 years ]
  3. Change in sleep quality [ Time Frame: At entry and every year for 5 years ]
  4. Prognosis [ Time Frame: At entry and every year for 5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: May 20, 2009    Key Record Dates
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