Vein of Galen MalformationNCT06595264
Vein of Galen Aneurysm
An observational study of Vein of Galen Malformation, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vein of Galen Malformation
- What is being tested?
- embolization therapy
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2024to 15 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients treated at Erasme for a vein of Galen malformation up to august 2024
Who may be able to join
- All patients treated at Erasme for a vein of Galen malformation
Who cannot join
- Opposition of parents to the use of medical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients With Aneurysms of the Vein of Galen, H.U.B Experience; a Retrospective Study
- 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.
- 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.
- 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.
- Design of the clinical research project: This is a retrospective study based on file analysis.
- 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
- Being tested
- embolization therapy
- Keywords
- vein of Galen aneurysm, neuroradiological embolization
- Medical subject headings
- Vein of Galen Malformations, Vein of Galen aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization therapyProcedure or surgery
Embolization in the neuroradiological department is the Golden Standard for the treatment of vein of Galen malformations.
| Study group | Role | What they receive |
|---|---|---|
| Vein of Galen malformation | All patients treated at Erasme hospital for a vein of Galen malformation. Receives: Procedure: embolization therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological outcome
Neurological outcome after each embolization therapy will be recorded (%): No neurological deficit, minor neurological deficit, major neurological deficit
Measured: 28 days
Secondary outcomes (2)
Cardiac failure
Presence of cardiac failure before, during and after each embolization therapy will be recorded. (%)
Measured: 28 days
Inotropic support
Inotropic support for heart failure will be recorded (%), as well as the type of inotropic agents used for treatment and maximum dosage.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion30 Apr 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vein of Galen MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis Schmartz, MD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595264
- Sponsor's protocol ID
- SRB2024207
- Status last verified
- May 2025
- First submitted
- 10 Sep 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashida Y, Miyahara H, Sawada H, Mitani Y, Maruyama K. Anesthetic management of a neonate with vein of Galen aneurysmal malformations and severe pulmonary hypertension. Paediatr Anaesth. 2005 Jun;15(6):525-8. doi: 10.1111/j.1460-9592.2005.01471.x.
PubMed 15910357Sinha PK, Neema PK, Rathod RC. Anesthesia and intracranial arteriovenous malformation. Neurol India. 2004 Jun;52(2):163-70.
PubMed 15269462Mortazavi MM, Griessenauer CJ, Foreman P, Bavarsad Shahripour R, Shoja MM, Rozzelle CJ, Tubbs RS, Fisher WS 3rd, Fukushima T. Vein of Galen aneurysmal malformations: critical analysis of the literature with proposal of a new classification system. J Neurosurg Pediatr. 2013 Sep;12(3):293-306. doi: 10.3171/2013.5.PEDS12587. Epub 2013 Jul 26.
PubMed 23889354
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Aneurysms of the Vein of Galen, H.U.B Experience; a Retrospective Study
- ClinicalTrials.gov ID
- NCT06595264
- Acronym / sponsor ID
- SRB2024207
- Conditions
- Vein of Galen Malformation
- Keywords
- vein of Galen aneurysm, neuroradiological embolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
- Design of the clinical research project: This is a retrospective study based on file analysis.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vein of Galen malformation | – | Procedure: embolization therapyAll patients treated at Erasme hospital for a vein of Galen malformation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients treated at Erasme for a vein of Galen malformation up to august 2024
Key inclusion criteria (1 listed)
- All patients treated at Erasme for a vein of Galen malformation
Key exclusion criteria (1 listed)
- Opposition of parents to the use of medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embolization therapyEmbolization in the neuroradiological department is the Golden Standard for the treatment of vein of Galen malformations. | Procedure or surgery | Vein of Galen malformation |
Primary outcome
Neurological outcome
Time frame: 28 days
Neurological outcome after each embolization therapy will be recorded (%): No neurological deficit, minor neurological deficit, major neurological deficit
2 secondary outcomes
Cardiac failure
Time frame: 28 days
Inotropic support
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 15910357Ashida Y, Miyahara H, Sawada H, Mitani Y, Maruyama K. Anesthetic management of a neonate with vein of Galen aneurysmal malformations and severe pulmonary hypertension. Paediatr Anaesth. 2005 Jun;15(6):525-8. doi: 10.1111/j.1460-9592.2005.01471.x.
- Background: PubMed 15269462Sinha PK, Neema PK, Rathod RC. Anesthesia and intracranial arteriovenous malformation. Neurol India. 2004 Jun;52(2):163-70.
- Background: PubMed 23889354Mortazavi MM, Griessenauer CJ, Foreman P, Bavarsad Shahripour R, Shoja MM, Rozzelle CJ, Tubbs RS, Fisher WS 3rd, Fukushima T. Vein of Galen aneurysmal malformations: critical analysis of the literature with proposal of a new classification system. J Neurosurg Pediatr. 2013 Sep;12(3):293-306. doi: 10.3171/2013.5.PEDS12587. Epub 2013 Jul 26.
- Individual participant dataSharing planned: No
Related trials for Vein of Galen Malformation
Recruiting
A Phase II Trial of Fetal Embolization for Vein of Galen Malformation
Vein of Galen Malformations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Schmartz, MD principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vein of Galen Malformation, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological outcome (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595264, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.