- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00675376
Evaluating Quality of Life for Patients With Chronic Obstructive Pulmonary Disease Who Are Undergoing Lung Transplantation
Lung Transplant for COPD: Outcomes/Technology
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine and Barnes-Jewish Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- Diagnosis other than COPD
- Inability to read English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Assessment of the effectiveness of lung transplantation in patients with COPD in the new donor lung allocation system
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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
Periodo de tiempo: Measured throughout the study
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Measured throughout the study
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Roger D. Yusen, MD, MPH, Washington University School of Medicine, St. Louis
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 564
- R01HL083067 (Subvención/contrato del NIH de EE. UU.)
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