Clinical trial NCT01524835: Live Lung Donor Cross-sectional Cohort Study
Official title: Live Lung Donor Cross-sectional Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Keywords: Tissue Donors
Lung
Transplants
Transplantation
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2012-02-02
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Live lung donors who participated in transplantation during 1993 through 2006

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

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 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

Primary outcomes:
measure: Spirometric lung function
timeFrame: Measured at time of scheduled spirometry testing
Secondary outcomes:
measure: Quality of life
timeFrame: Throughout study
measure: Morbidity
timeFrame: Throughout study
measure: Psychosocial status, including anxiety and depression symptoms
timeFrame: Throughout study
measure: Satisfaction with live lung donation
timeFrame: Throughout study
measure: Decision-making associated with live lung donation
timeFrame: Throughout study
measure: Representativeness of participating live lung donor study sample
timeFrame: Throughout study
measure: Predictors of donor outcome and/or status
timeFrame: Throughout study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: University of Southern California
name: Mark Barr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Roger Yusen, MD, MPH
role: STUDY_CHAIR
References:
citation: 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.