Vein of Galen Aneurysm
- Conditions
- Vein of Galen Malformation
- Interventions
- Procedure: embolization therapy
- Registration Number
- NCT06595264
- Lead Sponsor
- Erasme University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- All patients treated at Erasme for a vein of Galen malformation
- Opposition of parents to the use of medical data
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vein of Galen malformation embolization therapy All patients treated at Erasme hospital for a vein of Galen malformation.
- Primary Outcome Measures
Name Time Method Neurological outcome 28 days Neurological outcome after each embolization therapy will be recorded (%): No neurological deficit, minor neurological deficit, major neurological deficit
- Secondary Outcome Measures
Name Time Method Cardiac failure 28 days Presence of cardiac failure before, during and after each embolization therapy will be recorded. (%)
Inotropic support 28 days Inotropic support for heart failure will be recorded (%), as well as the type of inotropic agents used for treatment and maximum dosage.
Trial Locations
- Locations (1)
H.U.B - Hôpital Erasme
🇧🇪Bruxelles, Belgium