Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595264
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Vein of Galen Aneurysm
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patients with Aneurysms of the Vein of Galen HUB Experience a Retrospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
21 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
22 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
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
21 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
22 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None