Live Lung Donor Cross-sectional Cohort Study
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|ClinicalTrials.gov Identifier: NCT01524835|
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : March 27, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||192 participants|
|Official Title:||Live Lung Donor Cross-sectional Cohort Study|
|Study Start Date :||August 2010|
|Primary Completion Date :||September 2012|
|Study Completion Date :||October 2012|
Live lung donors
Live lung donors who participated in donation from 1993 through 2006
- Spirometric lung function [ Time Frame: Measured at time of scheduled spirometry testing ]
- Quality of life [ Time Frame: Throughout study ]
- Morbidity [ Time Frame: Throughout study ]
- Psychosocial status, including anxiety and depression symptoms [ Time Frame: Throughout study ]
- Satisfaction with live lung donation [ Time Frame: Throughout study ]
- Decision-making associated with live lung donation [ Time Frame: Throughout study ]
- Representativeness of participating live lung donor study sample [ Time Frame: Throughout study ]
- Predictors of donor outcome and/or status [ Time Frame: Throughout study ]
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): NCT01524835
|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|
|Principal Investigator:||Mark Barr, MD||University of Southern California|
|Study Chair:||Roger Yusen, MD, MPH||Washington University School of Medicine|