Live Lung Donor Cross-sectional Cohort Study

Lung Transplantation Clinical Trial

Official title:

Live Lung Donor Cross-sectional Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01524835
• Other study ID #: DAIT RELIVE-05
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: March 23, 2017
• Start date: August 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplantation

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometric lung function		Measured at time of scheduled spirometry testing
Secondary	Quality of life		Throughout study
Secondary	Morbidity		Throughout study
Secondary	Psychosocial status, including anxiety and depression symptoms		Throughout study
Secondary	Satisfaction with live lung donation		Throughout study
Secondary	Decision-making associated with live lung donation		Throughout study
Secondary	Representativeness of participating live lung donor study sample		Throughout study
Secondary	Predictors of donor outcome and/or status		Throughout study

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT) website
•   National Institute of Allergy and Infectious Diseases (NIAID) website