Chronic Subdural HematomaLEADHNCT05374681
Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization
A study testing Medical treatment, Surgical treatment and embolization of the MMA in people with Chronic Subdural Hematoma, run by University Hospital, Brest at 11 sites in France.
Trial summary
Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Medical treatment, Surgical treatment and embolization of the MMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 11 sitesFrance
- Study dates
- 28 Mar 2023to 28 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient with a more than 10 mm CSH confirmed by NCCT
- CSH localized to convexity
- Patient aged 18 years or more at the time of the enrollment
- Patient beneficiary from health insurance
Who cannot join
- Any contraindication as required per angiogram procedure (severe renal failure ≥ 4, allergy…)
- Pre-existing severe disability resulting in baseline mRS score > 3
- Life expectancy of less than 6 months due to another cause than CSH
- Patient under legal protection or deprived of liberty by a judicial or administrative decision
- Pregnant or breastfeeding women
- Vulnerable persons unable to give consent
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 8 recruiting
- Terminated
CHU Amiens-Picardie
Amiens, France, 80054
- Recruiting
CHU Bordeaux
Bordeaux, 33076
Gaultier MARNAT, Dr, gaultier.marnat@chu-bordeaux.fr
Gaultier MARNAT, Dr
- Recruiting
CHU Brest
Brest, France, 29609
Jean-Christophe GENTRIC, PhD, jean-christophe.gentric@chu-brest.fr
Jean-Christophe GENTRIC, PhD
- Terminated
CHU Caen
Caen, France, 14000
- Recruiting
Hôpital Henri Mondor
Créteil, France, 94000
Lucas SCARCIA, Dr, lucascarcia@icloud.com
Lucas SCARCIA, Dr
- Recruiting
CHU Nancy
Nancy, 54035
Benjamin GORY, Pr, B.GORY@chru-nancy.fr
Benjamin GORY, Pr
- Recruiting
CHU Nantes
Nantes, France, 44000
Romain BOURCIER, Dr, romain.bourcier@chu-nantes.fr
Romain BOURCIER, Dr
- Recruiting
CHU Nice
Nice, France, 06000
Michel LONJON, Pr, lonjon.m@chu-nice.fr
Michel LONJON, Pr
- Recruiting
Hôpital Pitié Salpêtrière
Paris, France, 75013
Frédéric CLARENCON, Pr, frederic.clarencon@aphp.fr
Frédéric CLARENCON, Pr
- Recruiting
Hôpital Fondation Rothschild
Paris, France, 75019
William BOISSEAU, Dr, wboisseau@for.paris
William BOISSEAU, Dr
- Terminated
CHU Tours
Tours, France, 37000
About this study
Official title: LEADH: Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization : Liquid Embolic Agent for the Treatment of Chronic subDural Hematoma a Randomized Control Study
Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose.
Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences.
The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.
Read the detailed description
- Indication of surgical or conservative management will be decided by the neurosurgeon.
- Experimental arm:
CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.
Medical management will be adopted according to neurosurgeons habits. MMA embolization (on the CSH side or bilaterally if necessary) in the Experimental Arms will be performed with Cyanoacrylates and preferentially using conscious sedation or local anesthesia.
- Control arm: CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.
Medical management will be adopted according to neurosurgeons habits
- Primary and secondary end points will be assessed at 2 months+/- 1 month and assessed at 6 +/- 2 months. The blind items will be the mRS and the RACE score. The volume of the CSH will be semi-automatically assessed using the ABC/2 method and the estimated maximal thickness of the CSH on axial images.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Medical treatment, Surgical treatment, embolization of the MMA
- Keywords
- Cyanoacrylate, Embolization, Middle meningeal artery, Recurrence of chronic subdural hematoma
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical treatmentOther
Medical treatment alone
Surgical treatmentOther
Surgical treatment alone
embolization of the MMAOther
The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA.
| Study group | Role | What they receive |
|---|---|---|
| Medical treatment alone | Other | Medical treatment without embolization of the MMA. Receives: Other: Medical treatment |
| Surgical treatment alone | Other | Surgical treatment without embolization of the MMA. Receives: Other: Surgical treatment |
| Medical treatment associated with an embolization of the MMA | Experimental | Medical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA. Receives: Other: Medical treatment; Other: embolization of the MMA |
| Surgical treatment associated with an embolization of the MMA | Experimental | Surgical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA. Receives: Other: Surgical treatment; Other: embolization of the MMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of CSH recurrence defined by the composite endpoint
CSH recurrence defined by the composite endpoint:
- A symptomatic CSH during the 6 month FU period
- A secondary surgical management during the 6 months FU period
- A remaining or reaccumulated hematoma on NCCT at 6 months
Measured: At 6 month
Secondary outcomes (14)
Number of symptomatic CSH during the FU period
Number of symptomatic CSH during the FU period
Measured: At 6 month
Number of secondary surgical management during the FU period
Number of secondary surgical management during the FU period
Measured: At 6 month
Number of remaining or reaccumulated hematoma on NCCT
Number of remaining or reaccumulated hematoma on NCCT
Measured: At 6 month
Clinical efficacy
Mortality rate
Measured: At 6 month
Clinical efficacy
Shift Modified Rankin Scale (mRS) (min = 0 = better outcome, max = 5 = worse outcome)
Measured: At 6 month
Clinical efficacy
Rapid Arterial oCclusion Exam (RACE) score evaluation (min = 0 = better outcome, max = 9 = worse outcome)
Measured: At 6 month
Clinical efficacy
Quality of life of patients will be evaluated by the EuroQol-5Dimensions-5L questionnaire
Measured: At 6 month
Clinical efficacy
Neurological exam : Barthel Scale (min = 0 = worse outcome, max = 100 = better outcome)
Measured: At 6 month
Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).
Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).
Measured: At 6 month
Complication rate of the embolization
Complication rate of the embolization
Measured: At 6 month
Volumetry of the CSH, calculated by the ABC/2 method.
Volumetry of the CSH, calculated by the ABC/2 method.
Measured: At 6 month
Maximum thickness of the CSH in mm.
Maximum thickness of the CSH in mm.
Measured: At 6 month
Comparison of the rate of AE in both groups
Comparison of the rate of AE in both groups
Measured: At 6 month
Comparison of the rate of SAE in both groups
Comparison of the rate of SAE in both groups
Measured: At 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start28 Mar 2023
- Primary completion28 Sep 2028 (estimated)
- Study completion28 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374681
- Sponsor's protocol ID
- 29BRC22.0028
- Acronym
- LEADH
- Status last verified
- Jun 2026
- First submitted
- 29 Apr 2022
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEADH: Efficacy of a Minimally Invasive Therapy Adjuvant to the Standards of Care by Cyanoacrylate Embolization : Liquid Embolic Agent for the Treatment of Chronic subDural Hematoma a Randomized Control Study
- ClinicalTrials.gov ID
- NCT05374681
- Acronym / sponsor ID
- LEADH / 29BRC22.0028
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Cyanoacrylate, Embolization, Middle meningeal artery, Recurrence of chronic subdural hematoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 28 Sep 2028 (estimated)
- Study completion
- 28 Sep 2028 (estimated)
- First posted
- 16 May 2022 (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.
Chronic subdural hematomas (CSH) are collections of blood in the subdural space. CSH are becoming the most common cranial neurosurgical condition among adults, and a significant public health problem, due to an increasing use of anticoagulant and antiplatelet medication in an ageing population. Symptomatic CSH, or CSH with a significant mass effect, are treated surgically. However, recurrences are common (10 to 20%). Conservative management (medical) is used in patients who are asymptomatic or have minor symptoms. However, therapeutic failures, requiring surgical treatment, are common. The pathophysiology of CSH involves inflammation, angiogenesis, and clotting dysfunction. Self-perpetuation and rebleeding is thought to be caused by neo-membranes from the inflammatory remodeling of the dura-mater mainly fed by the distal branches of the middle meningeal artery (MMA). There are 13 ongoing registered RCTs in CSH, with the most common covering application of steroids, surgical techniques and tranexamic acid. Further to this, there are trials running on other pharmacological agents, and peri-operative management. Some industrial or academic trials are or will enroll in France in the next year in France. But to our best knowledge, none of these trials will the eventual benefits of the MMA embolization in both cases of medical and/or surgical management, and none will focus on the use of cyanoacrylates (CYA) for this purpose.
Preliminary case series and nonrandomized retrospective studies have suggested that MMA embolization alone or as adjuvant therapy to surgery can decrease recurrences.
The investigators hypothesize that in both conditions of conservative or surgical managements, endovascular embolization of patients with CSH significantly reduces the risk of recurrence of CSH. The investigators choose the CYA as liquid embolic agent because of the pain and cost of the use of Ethylen Vinyl alcohol copolymer (EVOH) agents and its simplicity to be used.
Detailed description
- Indication of surgical or conservative management will be decided by the neurosurgeon.
- Experimental arm:
CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.
Medical management will be adopted according to neurosurgeons habits. MMA embolization (on the CSH side or bilaterally if necessary) in the Experimental Arms will be performed with Cyanoacrylates and preferentially using conscious sedation or local anesthesia.
- Control arm: CSH requiring hematoma removal will be surgically managed with a surgical technique applied depending on the surgeon's discretion.
Medical management will be adopted according to neurosurgeons habits
- Primary and secondary end points will be assessed at 2 months+/- 1 month and assessed at 6 +/- 2 months. The blind items will be the mRS and the RACE score. The volume of the CSH will be semi-automatically assessed using the ABC/2 method and the estimated maximal thickness of the CSH on axial images.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Medical treatment alone | Other | Other: Medical treatmentMedical treatment without embolization of the MMA. |
| Surgical treatment alone | Other | Other: Surgical treatmentSurgical treatment without embolization of the MMA. |
| Medical treatment associated with an embolization of the MMA | Experimental | Other: Medical treatment, Other: embolization of the MMAMedical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA. |
| Surgical treatment associated with an embolization of the MMA | Experimental | Other: Surgical treatment, Other: embolization of the MMASurgical treatment + embolization under local anesthesia or conscious sedation. The embolization will be carried out by femoral or radial arterial guided by pre-embolization cervical CTA. The middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with a more than 10 mm CSH confirmed by NCCT
- CSH localized to convexity
- Patient aged 18 years or more at the time of the enrollment
- Patient beneficiary from health insurance
Key exclusion criteria (6 listed)
- Any contraindication as required per angiogram procedure (severe renal failure ≥ 4, allergy…)
- Pre-existing severe disability resulting in baseline mRS score > 3
- Life expectancy of less than 6 months due to another cause than CSH
- Patient under legal protection or deprived of liberty by a judicial or administrative decision
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Medical treatmentMedical treatment alone | Other | Medical treatment alone, Medical treatment associated with an embolization of the MMA |
| Surgical treatmentSurgical treatment alone | Other | Surgical treatment alone, Surgical treatment associated with an embolization of the MMA |
| embolization of the MMAThe middle meningeal artery will be catheterized then embolized by cyanoacrylates until the occlusion of the MMA. | Other | Medical treatment associated with an embolization of the MMA, Surgical treatment associated with an embolization of the MMA |
Primary outcome
Number of CSH recurrence defined by the composite endpoint
Time frame: At 6 month
CSH recurrence defined by the composite endpoint: * A symptomatic CSH during the 6 month FU period * A secondary surgical management during the 6 months FU period * A remaining or reaccumulated hematoma on NCCT at 6 months
14 secondary outcomes
Number of symptomatic CSH during the FU period
Time frame: At 6 month
Number of secondary surgical management during the FU period
Time frame: At 6 month
Number of remaining or reaccumulated hematoma on NCCT
Time frame: At 6 month
Clinical efficacy
Time frame: At 6 month
Clinical efficacy
Time frame: At 6 month
Clinical efficacy
Time frame: At 6 month
Clinical efficacy
Time frame: At 6 month
Clinical efficacy
Time frame: At 6 month
Success rate of the embolization (success = technical success of the procedure. Failure of the procedure = total or partial (catheterization, injection, other)).
Time frame: At 6 month
Complication rate of the embolization
Time frame: At 6 month
Volumetry of the CSH, calculated by the ABC/2 method.
Time frame: At 6 month
Maximum thickness of the CSH in mm.
Time frame: At 6 month
Comparison of the rate of AE in both groups
Time frame: At 6 month
Comparison of the rate of SAE in both groups
Time frame: At 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical treatment, Surgical treatment and embolization of the MMA in people with Chronic Subdural Hematoma, run by University Hospital, Brest at 11 sites in France.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jean-Christophe GENTRIC, PhD (0298347520, jean-christophe.gentric@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of CSH recurrence defined by the composite endpoint (time frame: At 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2026.