Live Lung Donor Cross-sectional Cohort Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01524835
First received: January 31, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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


Condition
Lung Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Live Lung Donor Cross-sectional Cohort Study

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Spirometric lung function [ Time Frame: Measured at time of scheduled spirometry testing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Psychosocial status, including anxiety and depression symptoms [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Satisfaction with live lung donation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Decision-making associated with live lung donation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Representiveness of participating live lung donor study sample [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Predictors of donor outcome and/or status [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: August 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Live lung donors
Live lung donors who participated in donation from 1993 through 2006

Detailed Description:

Over time, the number of patients on the lung transplant waiting list and the number of lung transplants performed have greatly increased. Unfortunately, the number of patients on the waiting list has outpaced the transplant rate, resulting in a significant number of deaths for patients on the waiting list.

Live lung donation has the potential to decrease wait time for lung transplants and the rate of death for those awaiting transplants. However, since live lung donation typically utilizes one lobe of lung from each of two donors, transplantation puts two donors at risk for adverse events. Although live lung donation began in the early 1990s, there is still a great lack of published and comprehensive, long-term studies, leaving the outcome of live lung donation unclear. This study will assess post-donation outcomes in live lung donors. Specifically, investigators will determine the effects of live lung donation on lung function, quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. Information obtained from this study will allow potential future live lung donors and the interested public to become better informed, and may also assist potential donors in their decision-making process regarding the procedure. Furthermore, positive study results could potentially reassure previous live organ donors about uncertainties concerning their future health.

There will be 369 participants recruited for this study based on live lung donations, which occurred from 1993 through 2006. Study coordinators will contact eligible participants inviting participants to the study and answering any questions. Participants will have the option to partially or completely refuse participation. Each consenting donor will complete a series of questionnaires via phone and mail. The questions address issues related to the donor's quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. The questionnaires will take about one hour to complete. The coordinator will offer assistance regarding questionnaire completion and return. At the end of the study, a final brief status update will be obtained via phone interview.

In addition to questionnaires, participants will also be asked to participate in spirometry testing. For consenting participants, spirometry testing will be scheduled at either the two study sites or an approved Pulmonary Function Laboratory. During the test, the participant will breathe in and out of a plastic tube while a machine measures the amount and flow of air the donor breathes in and out. If deemed appropriate, the participant will do this test again a few minutes after being given albuterol, a drug which aims to optimize lung function. Spirometry testing will last about an hour.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Live lung donors who participated in transplantation during 1993 through 2006

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01524835

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Barr, MD University of Southern California
Study Chair: Roger Yusen, MD, MPH Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01524835     History of Changes
Other Study ID Numbers: DAIT RELIVE-05
Study First Received: January 31, 2012
Last Updated: June 3, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Tissue Donors
Lung
Transplants
Transplantation

ClinicalTrials.gov processed this record on April 16, 2014