Is the Preoperative Preparation of Sickle Cell Patients Optimal: Assessment of Practices and Post-operative Complications
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.
研究概览
地位
条件
研究类型
注册 (预期的)
联系人和位置
学习地点
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Brussles
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Brussels、Brussles、比利时、1020
- Hôpital Universitaire Des Enfants Reine Fabiola
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Sickle cell disease with surgery during the 2010-2019 period
Exclusion Criteria:
- None
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:追溯
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To assess the overall incidence of vaso-occlusive-events 1 month post surgery
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To assess the incidence of Vaso Occlusive Crisis 1 month post surgery
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:1 month after surgery
|
incidence of acute anemia with the presence of new allo-antibody(ies) against RBC
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1 month after surgery
|
|
To assess the incidence of RBC allo-immunization 3 months post surgery
大体时间: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
大体时间: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
大体时间:1 month after surgery
|
Number of RBC unit transfused
|
1 month after surgery
|
合作者和调查者
调查人员
- 首席研究员:Alina Ferster, MD、Queen Fabiola Children's University Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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