Bedside Evaluation of Coagulation in Children With Congenital Heart Disease (POCHEMO)
"Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease
The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry).
The investigators also aim to determine if this device detect post-cardiopulmonary bypass clotting derangements and may help to manage bleeding in this population.
Visão geral do estudo
Status
Descrição detalhada
Hemostasis, a main concern during and after any surgical procedure, is traditionally monitored by the following laboratory tests: activated Partial Thrombin Time (aPTT), prothrombin time (PT), fibrinogen, platelets count. They neither provide a reliable estimate of the risk of bleeding, nor allow determining useful interventions.
New investigations of hemostasis are now used and validated during and after surgery: Rotational Thromboelastometry (ROTEM®) and impedance aggregometry. This is a quick bedside functional analysis of the patient's clotting. Children who undergo surgery under cardiopulmonary bypass (CPB) are particularly at risk of bleeding and this population hasn't been studied with large cohort yet.
Hypothesis: Hemostasis in children with CHD, especially when cyanotic, is intrinsically abnormal. The corrective surgery on CPB induces further hemostatic disorders which can be identified by the ROTEM platelet®.
The aim of the study is to evaluate the hemostatic function of the child with congenital heart disease using a Point-Of-Care (platelet-ROTEM ®) system, before surgery and after alterations induced by cardiopulmonary bypass (CPB).
This is a single center, observational, prospective study. Expected duration: 2 years. The investigators plan to include 200 patients with CHD, 100 patients undergoing surgery with CPB and 100 patients with congenital heart disease requiring cardiac catheterization. Recruitment will be conducted by the Division of Paediatric Cardiology.
Inclusion criteria include an age of 0-16 years and a diagnosis of congenital heart disease requiring surgery with CPB or cardiac catheterization. Patients with known dyscrasia or treated with antiaggregant within 10 days/oral anticoagulants within 48h before surgery/catheterization.
ROTEM platelet® test will be performed before surgery/catheterization. Patients undergoing surgery will have a second test within 30 minutes after the end of cardiopulmonary bypass. All patients will benefit from the usual cares.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
Vaud
-
Lausanne, Vaud, Suíça, 1011
- PICU, Centre Hospitalier Universitaire Vaudois
-
-
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:
- children between 0 and 16 years, born with a congenital heart disease requiring either cardiac catheterization or surgery with cardiopulmonary bypass
- parental and/or patient consent
Exclusion Criteria:
- known hemostatic disorder
- known platelet function disorder
- antiaggregation treatment <10 days before blood sampling
- oral anticoagulation <2 days before blood sampling
- intravenous heparin <6 hours before blood sampling
- patient and parents unable to consent
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
Cardiopulmonary bypass
Children with congenital heart defect undergoing surgery on cardiopulmonary bypass
|
|
cardiac catheterism
Children with congenital heart defect undergoing cardiac catheterism
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Hemostasis measured by thromboelastometry and impedance aggregometry
Prazo: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
|
Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children
Prazo: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB)
Prazo: maximum 3 measurements, during surgery and up to 6 hours after end of CBP
|
maximum 3 measurements, during surgery and up to 6 hours after end of CBP
|
|
Thromboelastometry and impedance aggregometry changes in children with significant bleeding after CPB
Prazo: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Single measurement, during general anesthesia, immediately before procedure, when arterial line available
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stefano Di Bernardo, MD, CHUV
Publicações e links úteis
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
- 468/14
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 .