Transfusion and Coagulation Management in Trauma Patients After the Introduction of a Coagulation Algorithm
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Lucerne, Suíça, 6000
- Lucerne Kantonssital
-
Zurich, Suíça, 8091
- University Hospital Zürich
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Retrospectivo
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Timeframe 2005 - 2007
Data of timeframe 2005 up to 2007 will be included
|
|
Timeframe 2012 - 2014
Data of timeframe 2012 up to 2014 will be included
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
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.
Prazo: up to 48 hours
|
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.
|
up to 48 hours
|
|
Comparison of the rate of massive transfusion in reality with the predicted rate (by TASH) score.
Prazo: up to 48 hours
|
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.
|
up to 48 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Comparison of the predicted mortality (TRISS/RISC2) with the actual rate
Prazo: up to 30 days
|
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.
|
up to 30 days
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ZH 2015 - 0309
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .