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Patient Reported Outcomes in Living Donor Lung Transplantation

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ClinicalTrials.gov Identifier: NCT00905697
Recruitment Status : Active, not recruiting
First Posted : May 20, 2009
Last Update Posted : March 13, 2018
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 : April 2009
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

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Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Living donor lung transplantation
Living lung transplantation donors
 Procedure: Living donor lung transplantation
Living donor lung transplantation


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
Japan
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
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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: March 13, 2018
Last Verified: March 2018

Keywords provided by Toru Oga, Kyoto University, Graduate School of Medicine:
Living donor lung transplantation
Health-related quality of life
Prognosis
Patient reported outcome