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Is the Preoperative Preparation of Sickle Cell Patients Optimal: Assessment of Practices and Post-operative Complications

10 de fevereiro de 2020 atualizado por: Queen Fabiola Children's University Hospital

Is the Preoperative Preparation of Sickle Cell Patients Optimal: Retrospective Assessment of Practices and Post-operative Complications in a Cohort of Children Followed at Hôpital Universitaire Des Enfants Reine Fabiola (HUDERF) and Who Have Been Managed According Local Guidelines Including Transfusion or Exchange Transfusion Before Surgery

Children with sickle cell disease systematically receive a transfusion 2 to 5 days before scheduled surgery (with the exception of minor surgeries) in order to avoid post-operative complications of which the vaso-occlusive crisis and acute thoracic syndrome are the most frequent.

This standardized preoperative protocol was established on the basis of the results of large-scale randomized studies, most of which date back over ten years, and which have demonstrated the beneficial effects of transfusion (or transfusion exchange) preoperatively. To date, several other more recent studies (but not controlled) have questioned this type of systematic management.

The purpose of this study is to review retrospectively data of sickle cell children who have undergone elective surgery at the Huderf in the last ten years and to identify the eventual complications encountered. The most common procedures in these patients are: tonsillectomy with or without associated adenoids, splenectomy and cholecystectomy.

General data on sickle cell disease (history, genotype, G6PD deficiency, biology and previous complications), pre-surgical preparation, surgery and post surgical management and complications will be collected and analyzed.

This retrospective analysis will allow an objective assessment of the current quality of care and will provide useful data to improve patient management.

Visão geral do estudo

Status

Desconhecido

Condições

Anemia falciforme

Tipo de estudo

Observacional

Inscrição (Antecipado)

250

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Bélgica
- Brussles
  - Brussels, Brussles, Bélgica, 1020
    - Hopital Universitaire des Enfants Reine Fabiola

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 18 anos (Filho, Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Patients with sickle cell disease followed at Hôpital Universitaire des Enfants Reine Fabiola and having undergone a surgery betwee 2010-2019

Descrição

Inclusion Criteria:

Sickle cell disease with surgery during the 2010-2019 period

Exclusion Criteria:

None

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Modelos de observação: Coorte
Perspectivas de Tempo: Retrospectivo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
To assess the overall incidence of vaso-occlusive-events 1 month post surgery Prazo: 1 month after surgery	Vaso-occlusive-events will include Vaso Occlusive Crisis (acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)), acute chest syndrome (new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever) and hemoglobin < 6g/dl	1 month after surgery

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery Prazo: 1 month after surgery	Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)	1 month after surgery
To assess the incidence of Vaso Occlusive Crisis 3 months post surgery Prazo: 3 months after surgery	Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)	3 months after surgery
To assess the incidence of Vaso Occlusive Crisis 12 months post surgery Prazo: 12 months after surgery	Vaso Occlusive Crisis is defined as acute pain events that requires a visit to a medical facility and administration of pain medications (opioids or IV NSAIDs)	12 months after surgery
To assess the incidence of Acute Chest Syndrome 1 month post surgery Prazo: 1 month after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever	1 month after surgery
To assess the incidence of Acute Chest Syndrome 3 months post surgery Prazo: 3 months after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever	3 months after surgery
To assess the incidence of Acute Chest Syndrome 12 months post surgery Prazo: 12 months after surgery	Acute Chest Syndrome is defined as a new pulmonary infiltrate associated with by pneumonia-like symptoms, pain or fever	12 months after surgery
To assess the duration of hospitalization post-surgery Prazo: 1 month after surgery	number of days between surgery and day of discharge	1 month after surgery
To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery Prazo: 1 month after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC	1 month after surgery
To assess the incidence of RBC allo-immunization 3 months post surgery Prazo: 3 months after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC	3 months after surgery
To assess the incidence of RBC allo-immunization 12 months post surgery Prazo: 12 months after surgery	incidence of acute anemia with the presence of new allo-antibody(ies) against RBC	12 months after surgery
To assess the number of RBC transfusion episodes 1 month post surgery Prazo: 1 month after surgery	Number of RBC unit transfused	1 month after surgery

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Queen Fabiola Children's University Hospital

Investigadores

Investigador principal: Alina Ferster, MD, Queen Fabiola Children's University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2020

Conclusão Primária (Antecipado)

31 de maio de 2020

Conclusão do estudo (Antecipado)

30 de junho de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

7 de fevereiro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de fevereiro de 2020

Primeira postagem (Real)

11 de fevereiro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)