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Vein of Galen Aneurysm

NCT06595264 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2025-05-21

No results posted yet for this study

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.

Conditions

  • Vein of Galen Malformation

Interventions

PROCEDURE

embolization therapy

Embolization in the neuroradiological department is the Golden Standard for the treatment of vein of Galen malformations.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Denis Schmartz, MD · Université Libre de Bruxelles

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-04-30
Completion
2025-05-15

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06595264 on ClinicalTrials.gov