Heparin and the Reduction of Thrombosis (HART) Trial
Heparin and Catheter-related Thrombosis in Neonates and Infants Following Cardiac Surgery
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Patients are contacted pre-operatively and their parents consented. The following criteria apply:
Inclusion criteria:
All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital
Exclusion Criteria:
Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO
Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.
Thrombosis is demonstrated by echocardiogram or ultrasound performed at
1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.
The following are calculations for statistical analysis:
Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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California
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Stanford, California, Estados Unidos, 94305
- Stanford University School of Medicine
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital & #xA
Exclusion Criteria:
- Known coagulopathy
- History of clinically significant bleeding (GI, cranial, pulmonary)
- Need for therapeutic heparinization
- ECMO
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Study drug
Heparin sulfate infusion at 10 units/kg/hour
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Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery
Outros nomes:
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|
Comparador de Placebo: Placebo
Placebo - normal saline infusion
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Infusion of normal saline
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Thrombosis
Prazo: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
|
Echocardiographic evidence of thrombosis while on study drug
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first). Echoes were performed after 24-48 hours and then every 3-5 days
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Total PRBCs Transfused
Prazo: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Days to Extubation
Prazo: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Cardiac ICU Length of Stay
Prazo: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
|
Need for Antibiotics
Prazo: While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
While on study drug, which was continued until all catheters were removed, or 2 weeks (whichever came first)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Stephen J. Roth M.D., M.P.H., Stanford University
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SU-11132007-879
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