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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

未知

研究类型

观察性的

注册 (预期的)

250

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Brussles
      • Brussels、Brussles、比利时、1020
        • Hôpital Universitaire Des Enfants Reine Fabiola

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

Inclusion Criteria:

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

Exclusion Criteria:

  • None

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alina Ferster, MD、Queen Fabiola Children's University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月1日

初级完成 (预期的)

2020年5月31日

研究完成 (预期的)

2020年6月30日

研究注册日期

首次提交

2020年2月7日

首先提交符合 QC 标准的

2020年2月10日

首次发布 (实际的)

2020年2月11日

研究记录更新

最后更新发布 (实际的)

2020年2月11日

上次提交的符合 QC 标准的更新

2020年2月10日

最后验证

2020年1月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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