Evaluating Quality of Life for Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
|ClinicalTrials.gov Identifier: NCT00675376|
Recruitment Status : Unknown
Verified August 2013 by Washington University School of Medicine.
Recruitment status was: Enrolling by invitation
First Posted : May 9, 2008
Last Update Posted : August 20, 2013
|Condition or disease|
|Pulmonary Disease, Chronic Obstructive Lung Transplantation|
Lung transplantation is one treatment option for people with end-stage lung disease. The majority of people undergoing a lung transplant have COPD, and while transplantation can potentially improve survival and quality of life, it may also carry substantial risks, including surgical complications, infections, and pneumonia. The impact of lung transplantation on survival and quality of life has not been extensively studied. In the United States, the United Network for Organ Sharing (UNOS) is the organization that allocates donor lungs to lung recipients. Before 2005, the length of time that a candidate had been on the transplant waiting list was the major determining factor for receiving a donor lung. In mid 2005, the UNOS system changed and began prioritizing candidates on the basis of risk of death prior to lung transplantation and the probability of death within the first year after transplantation. The purpose of this study is to evaluate quality of life factors for lung transplant patients with COPD, both before and after the lung transplant procedure. In addition, quality of life of patients in the new UNOS allocation system will be compared with that of patients in the old UNOS allocation system.
This study will enroll all COPD patients undergoing an evaluation for lung transplantation at the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis, Missouri. Participants will attend study visits at the time of the transplant evaluation and again just prior to listing in the UNOS system. After the transplant, participants will attend study visits at Months 3 and 6 and then once a year for 5 years. During each study visit, participants will complete a computerized interview and health-related questionnaires that will assess quality of life factors, including social life, work life, and home life. Study researchers will also review participants' medical records to collect information on lung function and blood test results.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Lung Transplant for COPD: Outcomes/Technology|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
- Assessment of the effectiveness of lung transplantation in patients with COPD in the new donor lung allocation system [ Time Frame: Measured throughout the study ]
- Comparison of the effects of lung transplantation on the quality of life of patients with COPD in the new donor lung allocation system versus the old donor lung allocation system [ Time Frame: Measured throughout the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00675376
|United States, Missouri|
|Washington University School of Medicine and Barnes-Jewish Hospital|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Roger D. Yusen, MD, MPH||Washington University School of Medicine, St. Louis|