NCT01524835

Brief Summary

This study will gather information on the long-term effects of donating a lung lobe on living donors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

August 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

2.1 years

First QC Date

January 31, 2012

Last Update Submit

March 23, 2017

Conditions

Keywords

Tissue DonorsLungTransplantsTransplantation

Outcome Measures

Primary Outcomes (1)

  • Spirometric lung function

    Measured at time of scheduled spirometry testing

Secondary Outcomes (7)

  • Quality of life

    Throughout study

  • Morbidity

    Throughout study

  • Psychosocial status, including anxiety and depression symptoms

    Throughout study

  • Satisfaction with live lung donation

    Throughout study

  • Decision-making associated with live lung donation

    Throughout study

  • +2 more secondary outcomes

Study Arms (1)

Live lung donors

Live lung donors who participated in donation from 1993 through 2006

Eligibility Criteria

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

Live lung donors who participated in transplantation during 1993 through 2006

You may qualify if:

  • Donated a lung at University of Southern California or Washington University between January 1, 1993 and December 31, 2006

You may not qualify if:

  • For questionnaire testing: inability to comprehend and complete questionnaires (with assistance)
  • For spirometry: self-reported pregnancy, inability to reproducibly perform, and contraindications
  • For post-bronchodilator spirometry: allergy to albuterol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Yusen RD, Hong BA, Messersmith EE, Gillespie BW, Lopez BM, Brown KL, Odim J, Merion RM, Barr ML; RELIVE Study Group. Morbidity and mortality of live lung donation: results from the RELIVE study. Am J Transplant. 2014 Aug;14(8):1846-52. doi: 10.1111/ajt.12771.

Related Links

Study Officials

  • Mark Barr, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR
  • Roger Yusen, MD, MPH

    Washington University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 2, 2012

Study Start

August 1, 2010

Primary Completion

September 1, 2012

Study Completion

October 1, 2012

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Available IPD Datasets

Individual Participant Data Set (SDY294)Access
Study Protocol (SDY294)Access
Study summary, -design, -demographics, -study files (SDY294)Access

Locations