跳至主要内容
临床试验/NCT00675376
NCT00675376终止不适用

Lung Transplant for COPD: Outcomes/Technology

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 419 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
419
试验地点
1
主要终点
Assessment of the effectiveness of lung transplantation in patients with COPD in the new donor lung allocation system

研究概览

简要总结

Most people undergoing lung transplantation have chronic obstructive pulmonary disease (COPD), a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. This study will enroll people with COPD who are undergoing a lung transplant to examine how their quality of life changes after the transplant procedure.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred to the adult lung transplant program
  • Undergoing evaluation for lung transplantation
  • Very severe COPD (Global Initiative for Chronic Obstructive Lung Disease [GOLD] class IV) that is predominantly due to emphysema
  • Able to read English
  • Able to adequately see a computer screen

排除标准

  • Diagnosis other than COPD
  • Inability to read English

结局指标

主要结局

Assessment of the effectiveness of lung transplantation in patients with COPD in the new donor lung allocation system

时间窗: Measured throughout the study

次要结局

  • 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(Measured throughout the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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