Subdural Hematoma, ChronicNCT06274580
Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms
A study testing embolization of the middle meningeal artery in people with Subdural Hematoma, Chronic, run by Ospedale Policlinico San Martino.
Trial summary
Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subdural Hematoma, Chronic
- What is being tested?
- embolization of the middle meningeal artery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 1 Mar 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No neurological deficits (Markwalder score ≤1);
- Unilateral or bilateral cSDH;
- Subdural Hematoma width ≤ 20 mm; midline shift ≤ 7mm;
- Independent functional status with mRS score ≤ 2 prior to symptom onset;
- Likely compliance of the participant in attending follow-up examination.
Who cannot join
- Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma;
- Contraindications to angiography (end stage chronic renal disease, any sign of anatomical variations that could make MMA embolization unsafe, pregnancy);
- Life expectancy < 1 year;
- Patients with any kind of ventricular derivation catheter.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms: a Multicentre Randomized Trial
Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.
Read the detailed description
Patients randomized to the experimental arm will submit to cerebral angiography and bilateral MMA embolization of the cSHD, even if it is located to only one side. The ipsilateral MMA embolization of the cSDH is allowed when the endovascular procedure cannot be performed on both sides. Patients are preferably under monitored local anesthesia or alternatively under conscious sedation or general anesthesia. Briefly, through femoral or radial artery access a standard 5 French diagnostic catheter is placed in the proximal external carotid artery and a digital subtraction angiography (DSA) is performed. Then, a microcatheter is advanced selectively under roadmap guidance into the main trunk of MMA, and superselective angiography is performed to evaluate for potentially dangerous anastomoses between MMA and ophthalmic or petrous branches prior to embolization. After collateral vessels are excluded, the MMA is occluded with PVA particles or liquid embolizing materials . The successful embolization is defined as that both frontal and parietal branch of MMA are selectively occluded and for this purpose, the microcatheter should be placed as distally as possible. It is recommended to ensure embolic materials penetrating into the capillary network of the dura to be permanently blocked. Patients randomized to the conservative arm will be clinmically monitored and eventually receive a best supportive care according to the local practice.
The trial is powered to assess superiority. When assuming the event rate of 1% in intervention group and 10% event rate in the control group, with a power of 85% and two-sided alpha of 0.05, allowing for 10% drop-outs, the estimated sample size is 300 patients in total.
The safety and efficacy interim analysis will be planned when half of the target sample (150 patients) completed 6 months follow-up. The enrollment will be stopped if the futility assessment based on estimated conditional power will be <70%.
All patient data is registered in the electronic data capture software REDCap. This worldwide online system allows built-in logical checks and validations to promote data quality. All clinical data are entered via an encrypted connection, are anonymized, and fulfill the demands for data protection. All data entries and changes are logged in REDCap and meet the Good Clinical Practice (GCP) requirements for the use of the electronic case report form (eCRF) in medical trials. Trial coordinators, data managers and the investigators will be introduced to the platform and trained in data entry during the initial kick-of meeting prior to recruitment of the first patient. Trial staff will be provided with a personal ID.
Currently, 6 centers in Italy have been identified for the study. All the clinical investigators are board-certified and have renowned expertise in neurosurgery, neuroradiology and endovascular interventions.
- Conditions
- Subdural Hematoma, Chronic
- Being tested
- embolization of the middle meningeal artery
- Keywords
- subdural hematoma, chronic, embolization, middle meningeal artery
- Medical subject headings
- Hematoma, Subdural, Chronic, Hematoma, Subdural, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolization of the middle meningeal arteryDevice
Embolization of the MMA is occluded with PVA particles or liquid embolizing materials
| Study group | Role | What they receive |
|---|---|---|
| Embolization of the middle meningeal artery | Experimental | Endovascular treatment of chronic subdural hematoma Receives: Device: embolization of the middle meningeal artery |
| standard of care | No intervention | control group will managed according to the current standard of care with "wait and see" approach and best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incomplete hematoma resolution or surgical rescue
Incomplete hematoma resolution is defined as a reduction of the cSDH thickness ≤50% at follow-up compared to the hematoma thickness measured at the time of randomization. Surgical rescue is intended as hematoma removal for relief of symptoms (mRS≥3 and Markwalder scale≥2) that develope with progressive growth of the cSDH
Measured: 6 months
Secondary outcomes (2)
treatment complication
Procedure related complication during or 30 days after MMA embolization
Measured: 30 days
treatment successful
Successful embolization rate of the target vessels based on angiographic findings
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Subdural Hematoma, ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Castellan, Ospedale Policlinico San Martino
- Investigators
- Lucio Castellan, MD, Principal investigator, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274580
- Sponsor's protocol ID
- 5916
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
PubMed 19782872Kim HC, Ko JH, Yoo DS, Lee SK. Spontaneous Resolution of Chronic Subdural Hematoma : Close Observation as a Treatment Strategy. J Korean Neurosurg Soc. 2016 Nov;59(6):628-636. doi: 10.3340/jkns.2016.59.6.628. Epub 2016 Oct 24.
PubMed 27847578Rojas-Villabona A, Mohamed S, Kennion O, Padmanabhan R, Siddiqui A, Prasad M, Mukerji N. A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation. Brain Spine. 2023 Sep 6;3:102672. doi: 10.1016/j.bas.2023.102672. eCollection 2023.
PubMed 38021007Akamatsu Y, Kashimura H, Kojima D, Yoshida J, Chika K, Komoribayashi N, Fujiwara S, Ogasawara K. Correlation Between Low-Density Hematoma at 1-Week Post-Middle Meningeal Artery Embolization and Rapid Resolution of Chronic Subdural Hematoma. World Neurosurg. 2024 Jan;181:e1088-e1092. doi: 10.1016/j.wneu.2023.11.045. Epub 2023 Nov 17.
PubMed 37979682Omura Y, Ishiguro T. Middle meningeal artery embolization for chronic subdural hematoma: a systematic review. Front Neurol. 2023 Oct 10;14:1259647. doi: 10.3389/fneur.2023.1259647. eCollection 2023.
PubMed 37881312Salsano G, Fiaschi P, Laura G, Sonia M, Fontana V, Boni L, Zona G, Castellan L. Endovascular vs conservative treatment in patients with chronic subdural hematomas and mild symptoms: a study protocol for a multicenter randomized controlled trial (EMBOTRIAL-1). Trials. 2025 Nov 18;26(1):517. doi: 10.1186/s13063-025-09131-y.
PubMed 41254694
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms: a Multicentre Randomized Trial
- ClinicalTrials.gov ID
- NCT06274580
- Acronym / sponsor ID
- 5916
- Conditions
- Subdural Hematoma, Chronic
- Keywords
- subdural hematoma, chronic, embolization, middle meningeal artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 23 Feb 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.
Embotrial-1 is an Italian multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment (PROBE) to assess the superiority of MMA embolization compared to conservative treatment. The intervention group is MMA embolization and comparator control group is the conservative management with best medical treatment. Patients are randomized 1:1.
Detailed description
Patients randomized to the experimental arm will submit to cerebral angiography and bilateral MMA embolization of the cSHD, even if it is located to only one side. The ipsilateral MMA embolization of the cSDH is allowed when the endovascular procedure cannot be performed on both sides. Patients are preferably under monitored local anesthesia or alternatively under conscious sedation or general anesthesia. Briefly, through femoral or radial artery access a standard 5 French diagnostic catheter is placed in the proximal external carotid artery and a digital subtraction angiography (DSA) is performed. Then, a microcatheter is advanced selectively under roadmap guidance into the main trunk of MMA, and superselective angiography is performed to evaluate for potentially dangerous anastomoses between MMA and ophthalmic or petrous branches prior to embolization. After collateral vessels are excluded, the MMA is occluded with PVA particles or liquid embolizing materials . The successful embolization is defined as that both frontal and parietal branch of MMA are selectively occluded and for this purpose, the microcatheter should be placed as distally as possible. It is recommended to ensure embolic materials penetrating into the capillary network of the dura to be permanently blocked. Patients randomized to the conservative arm will be clinmically monitored and eventually receive a best supportive care according to the local practice.
The trial is powered to assess superiority. When assuming the event rate of 1% in intervention group and 10% event rate in the control group, with a power of 85% and two-sided alpha of 0.05, allowing for 10% drop-outs, the estimated sample size is 300 patients in total.
The safety and efficacy interim analysis will be planned when half of the target sample (150 patients) completed 6 months follow-up. The enrollment will be stopped if the futility assessment based on estimated conditional power will be <70%.
All patient data is registered in the electronic data capture software REDCap. This worldwide online system allows built-in logical checks and validations to promote data quality. All clinical data are entered via an encrypted connection, are anonymized, and fulfill the demands for data protection. All data entries and changes are logged in REDCap and meet the Good Clinical Practice (GCP) requirements for the use of the electronic case report form (eCRF) in medical trials. Trial coordinators, data managers and the investigators will be introduced to the platform and trained in data entry during the initial kick-of meeting prior to recruitment of the first patient. Trial staff will be provided with a personal ID.
Currently, 6 centers in Italy have been identified for the study. All the clinical investigators are board-certified and have renowned expertise in neurosurgery, neuroradiology and endovascular interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Embolization of the middle meningeal artery | Experimental | Device: embolization of the middle meningeal arteryEndovascular treatment of chronic subdural hematoma |
| standard of care | No intervention | –control group will managed according to the current standard of care with "wait and see" approach and best medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No neurological deficits (Markwalder score ≤1);
- Unilateral or bilateral cSDH;
- Subdural Hematoma width ≤ 20 mm; midline shift ≤ 7mm;
- Independent functional status with mRS score ≤ 2 prior to symptom onset;
- Likely compliance of the participant in attending follow-up examination.
Key exclusion criteria (4 listed)
- Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma;
- Contraindications to angiography (end stage chronic renal disease, any sign of anatomical variations that could make MMA embolization unsafe, pregnancy);
- Life expectancy < 1 year;
- Patients with any kind of ventricular derivation catheter.
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 of the middle meningeal arteryEmbolization of the MMA is occluded with PVA particles or liquid embolizing materials | Device | Embolization of the middle meningeal artery |
Primary outcome
Rate of incomplete hematoma resolution or surgical rescue
Time frame: 6 months
Incomplete hematoma resolution is defined as a reduction of the cSDH thickness ≤50% at follow-up compared to the hematoma thickness measured at the time of randomization. Surgical rescue is intended as hematoma removal for relief of symptoms (mRS≥3 and Markwalder scale≥2) that develope with progressive growth of the cSDH
2 secondary outcomes
treatment complication
Time frame: 30 days
treatment successful
Time frame: periprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Results publication: PubMed 19782872Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
- Results publication: PubMed 27847578Kim HC, Ko JH, Yoo DS, Lee SK. Spontaneous Resolution of Chronic Subdural Hematoma : Close Observation as a Treatment Strategy. J Korean Neurosurg Soc. 2016 Nov;59(6):628-636. doi: 10.3340/jkns.2016.59.6.628. Epub 2016 Oct 24.
- Results publication: PubMed 38021007Rojas-Villabona A, Mohamed S, Kennion O, Padmanabhan R, Siddiqui A, Prasad M, Mukerji N. A systematic review of middle meningeal artery embolization for minimally symptomatic chronic subdural haematomas that do not require immediate evacuation. Brain Spine. 2023 Sep 6;3:102672. doi: 10.1016/j.bas.2023.102672. eCollection 2023.
- Results publication: PubMed 37979682Akamatsu Y, Kashimura H, Kojima D, Yoshida J, Chika K, Komoribayashi N, Fujiwara S, Ogasawara K. Correlation Between Low-Density Hematoma at 1-Week Post-Middle Meningeal Artery Embolization and Rapid Resolution of Chronic Subdural Hematoma. World Neurosurg. 2024 Jan;181:e1088-e1092. doi: 10.1016/j.wneu.2023.11.045. Epub 2023 Nov 17.
- Results publication: PubMed 37881312Omura Y, Ishiguro T. Middle meningeal artery embolization for chronic subdural hematoma: a systematic review. Front Neurol. 2023 Oct 10;14:1259647. doi: 10.3389/fneur.2023.1259647. eCollection 2023.
- Derived from this study: PubMed 41254694Salsano G, Fiaschi P, Laura G, Sonia M, Fontana V, Boni L, Zona G, Castellan L. Endovascular vs conservative treatment in patients with chronic subdural hematomas and mild symptoms: a study protocol for a multicenter randomized controlled trial (EMBOTRIAL-1). Trials. 2025 Nov 18;26(1):517. doi: 10.1186/s13063-025-09131-y.
- Individual participant dataSharing planned: No
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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.
Lucio Castellan, MD principal investigator
Ospedale Policlinico San Martino
Questions about this trial
What is this clinical trial studying?
A study testing embolization of the middle meningeal artery in people with Subdural Hematoma, Chronic, run by Ospedale Policlinico San Martino.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucio Castellan, MD (+390105552262, lucio.castellan@hsanmartino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of incomplete hematoma resolution or surgical rescue (time frame: 6 months). 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 NCT06274580, which also lists 6 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 23 Feb 2024.