- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02569606
Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Trauma is one of the leading causes of death worldwide. After death due to direct craniofacial injury, exsanguination is the next major cause for trauma mortality.
After initial pre-hospital treatment the patient is admitted to the hospital. If multiple injuries are present the patient is transferred to a specialized trauma center.
Besides surgical treatment, the patient needs stabilization of the vital functions by the Anesthesiologist. Due to loss of blood volume, dilution of the circulatory blood volume and pathological activation of coagulation/fibrinolysis, trauma induced coagulopathy (TIC) is initiated. This needs to be treated and avoided whenever possible.
Transfusion of allogeneic blood and coagulation product itself leads to an increased morbidity and mortality. Infectious and immunologic reactions account for that phenomenon.
This led to a paradigm change in the therapy of TIC. In 2009 a new coagulation factor based coagulation algorithm was introduced in the Hospital Lucerne and the University Hospital in Zurich / Switzerland. With the help of point of care coagulation measurement, tailored coagulation factor based coagulation management and avoidance of allogeneic blood products was initiated.
The investigators now want to analyze the impact of the coagulation algorithm by comparing the periods before and after the introduction of the algorithm.
The consumption of blood and coagulation products (packed red blood cells, fresh frozen plasma, platelet concentrates, fibrinogen, coagulation factor concentrates, coagulation factor XIII, activated factor VII, van Willebrand factor and antifibrinolytics) before and after the introduction of a designated trauma related transfusion and coagulation algorithm will be recorded and compared. The periods 2005-2007 (before) and 2012-2014 (after) the introduction are reviewed. Predicted probability of a massive transfusion by the TASH score (trauma associated acute hemorrhage) is correlated with the actual rate.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Lucerne, Suiza, 6000
- Lucerne Kantonssital
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Zurich, Suiza, 8091
- University Hospital Zürich
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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:
- male and female trauma patients
- admitted to the University hospital of Zurich or the Hospital of Lucerne, Switzerland
- injury severity score >= 16
- time period 2005-2007 and 2012-2014
Exclusion Criteria:
- incomplete data
- denial of informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
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Timeframe 2005 - 2007
Data of timeframe 2005 up to 2007 will be included
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Timeframe 2012 - 2014
Data of timeframe 2012 up to 2014 will be included
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Comparison the consumption of red blood cells, fresh frozen plasma and platelets in the treatment period by the Anaesthesist and after 24/48 hours before (2005-2007) and after (2012-2014) launching the coagulation algorithm.
Periodo de tiempo: up to 48 hours
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The coagulation algorithm was launched in 2010.
To show the difference in transfusion and administration of coagulation products prior and after the changes of coagulation algorithm the probability of massive transfusion (TASH Score) will be compared with the actual rate.
The TASH Score is the most precise predictive probability of a massive transfusion.
Data of approximately 1800 participants will be compared.
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up to 48 hours
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Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.
Periodo de tiempo: up to 48 hours
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Massive transfusion (>10 units of blood) can be predicted on the base of patient and trauma epidemiology.
The investigator compares the actual rate in the institution with the rate predicted by the score.
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up to 48 hours
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Comparison of the predicted mortality (TRISS/RISC2) with the actual rate
Periodo de tiempo: up to 30 days
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TRISS is a common Score and is a comparative value for trauma mortality outcome.
The investigators want to show the benefit of launched coagulation algorithm in mortality after severe trauma.
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up to 30 days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
- ZH 2015 - 0309
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