NCT00905697

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

10.3 years

First QC Date

May 18, 2009

Last Update Submit

August 27, 2019

Conditions

Keywords

Living donor lung transplantationHealth-related quality of lifePrognosisPatient reported outcome

Outcome Measures

Primary Outcomes (1)

  • Change in health status

    At entry and every year for 5 years

Secondary Outcomes (4)

  • 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

    At entry and every year for 5 years

  • Prognosis

    At entry and every year for 5 years

Study Arms (1)

Living donor lung transplantation

Living lung transplantation donors

Procedure: Living donor lung transplantation

Interventions

Living donor lung transplantation

Living donor lung transplantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Kyoto University Hospital Clinic for Lung Transplantation

You may qualify if:

  • New donors for living donor lung transplantation

You may not qualify if:

  • Inability to obtain informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate School of Medicine, Kyoto University

Kyoto, Japan

Location

Study Officials

  • Hiroshi Date, MD, PhD

    Graduate School of Medicine, Kyoto University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respiratory Care and Sleep Control Medicine

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

April 1, 2009

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations