- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02367768
Long-term Outcome Related Prognostic Factor and Biomarkers of Major Trauma Database Analysis
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Severe traumatic injury occupied the sixth leading cause of death in Taiwan, especially in young adults. In 2013, there were accidental deaths in every 76 minutes. Not compared with the malignancy, heart disease, cerebrovascular disease, diabetes mellitus, or pneumonia Since 1995, Taiwan replaced a previous patchwork of separate social health insurance funds with one single-payer, National Health Insurance (NHI) scheme that is administered by an agency of the central government's Department of Health. NHI supported the cost of Critical Illness and Injury that numerous patients with major trauma were eligible for preference. However, the national medical cost of trauma care, especially in poly-trauma or major trauma were impressive: the adjusted national inpatient trauma yearly costs were estimated at $37,511,328,659 US dollars; the national insurance cost provided by Bureau of National Health Insurance, Department of Health for trauma was over $20,000,000,000 new Taiwan dollars till 1999 with increasing yearly.
Recently it flashed bulletins nationwide and overseas for catastrophes, such as aircraft accident, wrecks, or underground gas explosions. There was a stirring of interest in life support system for major trauma related rescue from dying. Death to trauma is caused by costly damages on scene, hemorrhage shock or trauma and massive transfusion related acute respiratory distress syndrome (ARDS). Extra-Corporeal Membrane Oxygenation (ECMO) can rescue life from severe cardiopulmonary failure, but coexisting complication as bleeding and coagulopathy restricting the utilization the use in trauma patients. Besides, there were more portable ECMO sets making a debut, especially for air transportation. It act now the medical transferral for trauma patients under ECMO support. The portable ECMO sets launched with possibility, accessibility, and convenience. The issue of life support system utilization, long-term outcome, and medical cost-effectiveness for major trauma patients was worth discussing no matter in National Taiwan University Hospital (NTUH) trauma database or National Health Insurance Research Database (NHIRD).
Immune system alteration was previously considered the mechanism of post-traumatic stress disorder (PTSD). Moreover, an externally experienced traumatic event induces downstream alterations in immune function by reducing methylation.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ying-Ru Chen, Master
- Número de teléfono: 886972651471
- Correo electrónico: ronaldinhol@hotmail.com
Copia de seguridad de contactos de estudio
- Nombre: Ying-Ru Chen, Master
- Número de teléfono: 886972651471
Ubicaciones de estudio
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Taipei City, Taiwán, 100
- Reclutamiento
- National Taiwan University Hospital
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Contacto:
- Ting-Chun Kuo
- Número de teléfono: 886-97265-3245
- Correo electrónico: tina@ntuh.gov.tw
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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:
- age ≧ 20
- willing to join this study and sign the inform consent form by the patients or their contactable families
- ISS score ≧ 16, or meet trauma blue or trauma red criteria
- response to primary resuscitation
- without uncontrolled or major (>1500mL) bleeding.
Exclusion criteria:
- active malignancy before the event of major trauma
- age <20, pregnancy woman, breast-feeding woman, or mental illness
- uncontrolled bleeding with hemoglobin <7g/dL after treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Event related survival
Periodo de tiempo: 30 days
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since major trauma event till trauma related death
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30 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Functional status
Periodo de tiempo: 12 months
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Besides Rehabilitation Complexity Scale (RCS) and Functional Independence Measure (FIM) for traumatic brain injury patients, Glasgow Outcome Scale - Extended (GOS-E) and European Quality of Life Five Dimensions Questionnaire (EQ-5D) are used in concerning longer-term outcome indicators.
There are currently no robust measures of patient experience for use in major trauma.
Functional status after the major trauma event could be measured using non-clinical outcomes such as return to work, maintenance of education and societal dependency at post injury 3, 6, and 12 months.
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12 months
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over all survival
Periodo de tiempo: 2 years
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since major trauma event till death
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2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ting-Chun Kuo, M.D., No.7, Chung San South Road, Taipei City 100, Taiwan (R.O.C.)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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 (Estimar)
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
- 201410060RINA
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