Patient Reported Outcomes in Living Donor Lung Transplant... | NCT00905697

Studies
Patient Reported Outcomes in Living Donor Lung Transplantation

NCT00905697

Sponsor

Kyoto University, Graduate School of Medicine

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Lung Transplantation

Interventions

Living donor lung transplantation

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Aug 2019Actual

Completion Date

Aug 2019Actual

First Submitted Date

May 18, 2009

First Submission Date that Met QC Criteria

May 18, 2009

First Posted Date

May 20, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Toru Oga, Department of Respiratory Care and Sleep Control Medicine, Kyoto University, Graduate School of MedicinePrincipal Investigator

Lead Sponsor

Kyoto University, Graduate School of MedicineOTHER

Collaborators

Name	Class
Ministry of Health, Labour and Welfare, Japan	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Living donor lung transplantation		Living lung transplantation donors	Procedure: Living donor lung transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Living donor lung transplantation	Procedure	Living donor lung transplantation	Living donor lung transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in health status		At entry and every year for 5 years

Secondary Outcomes

Measure	Description	Time Frame
Change in dyspnea		At entry and every year for 5 years
Change in psychological status		At entry and every year for 5 years
Change in sleep quality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

New donors for living donor lung transplantation

Exclusion Criteria:

Inability to obtain informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Kyoto University Hospital Clinic for Lung Transplantation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Date, MD, PhD	Graduate School of Medicine, Kyoto University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Graduate School of Medicine, Kyoto University		Kyoto			Japan