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临床试验/NCT06595264
NCT06595264已完成不适用

Patients With Aneurysms of the Vein of Galen, H.U.B Experience; a Retrospective Study

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
Neurological outcome

研究概览

简要总结

  1. Foundations of the clinical research project:

Vein of Galen vascular malformations are a group of rare cerebral vascular malformations with complex anatomy and severe clinical consequences. The pathology consists of direct communications between small intracerebral arteries and veins without the presence of capillaries. The result is a vascular malformation with low resistance and high flow, a lesion that will evolve during fetal development into aneurysmal dilatation.

These lesions evolve towards rupture, but due to the high flow rate through these malformations, children very quickly develop cardiac decompensation (high-output failure). Treatment must be rapid, often on the first day of life. The technique currently used is iterative embolization. General anaesthesia is required for this procedure. However, neonatal anesthesia in children with cardiac decompensation and pulmonary hypertension poses major challenges for the anesthesia team. A high percentage of these patients require a short stabilization period with management of cardiac decompensation and pulmonary hypertension, most often by continuous milrinone infusion.

Hôpital Erasme is a reference center for the management of vein of Galen malformations. In this work, we propose to analyze all cases of children with veins of Galen malformations managed by the interventional neuroradiology department. 2. Objectives of the clinical research project:

2.1 Main objective:

Description of cerebral lesions as described by angiography. Details of anesthetic management with all anesthetic drugs, details of cardiac management. Details of ventilatory management, intubation duration required.

Description of embolization outcome. Description of the neurological and cardiac outcome.

2.2 Secondary objectives:

Possibly, depending on the number of patients, attempt to identify factors predictive of poor outcome. 3. Methodology of the clinical research project:

We will carry out a retrospective analysis of the records of all patients who have been managed at Erasme for vein of Galen-type malformation. Activity began ± in 2011, and we will produce a listing of all patients from 2010 to August 2024. From this listing, obtained by the radiology department, we will collect data from the patients computer files. 4. Design of the clinical research project:

This is a retrospective study based on file analysis. 5. Participants:

All patients treated at Erasme for a vein of Galen malformation. We will check the file to ensure that the parents have not expressed any opposition to the use of the patient medical data.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients treated at Erasme for a vein of Galen malformation

排除标准

  • Opposition of parents to the use of medical data

结局指标

主要结局

Neurological outcome

时间窗: 28 days

Neurological outcome after each embolization therapy will be recorded (%): No neurological deficit, minor neurological deficit, major neurological deficit

次要结局

  • Cardiac failure(28 days)
  • Inotropic support(28 days)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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