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临床试验/NCT04264871
NCT04264871Unknown不适用

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

Queen Fabiola Children's University Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
To assess the overall incidence of vaso-occlusive-events 1 month post surgery

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Sickle cell disease with surgery during the 2010-2019 period

排除标准

  • 未提供

结局指标

主要结局

To assess the overall incidence of vaso-occlusive-events 1 month post surgery

时间窗: 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

次要结局

  • To assess the number of RBC transfusion episodes 1 month post surgery(1 month after surgery)
  • To assess the incidence of Acute Chest Syndrome 12 months post surgery(12 months after surgery)
  • To assess the incidence of Red Blood Cell (RBC) allo-immunization 1 month post surgery(1 month after surgery)
  • To assess the incidence of RBC allo-immunization 12 months post surgery(12 months after surgery)
  • To assess the incidence of Vaso Occlusive Crisis 3 months post surgery(3 months after surgery)
  • To assess the incidence of Acute Chest Syndrome 1 month post surgery(1 month after surgery)
  • To assess the incidence of RBC allo-immunization 3 months post surgery(3 months after surgery)
  • To assess the incidence of Vaso Occlusive Crisis 12 months post surgery(12 months after surgery)
  • To assess the incidence of Acute Chest Syndrome 3 months post surgery(3 months after surgery)
  • To assess the duration of hospitalization post-surgery(1 month after surgery)
  • To assess the incidence of Vaso Occlusive Crisis 1 month post surgery(1 month after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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