EpiDural HematomaAEDH-MTNCT06292585
Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
A study testing MMA embolization plus medical therapy and Medical therapy alone in people with EpiDural Hematoma and Traumatic Brain Injury, run by Changhai Hospital at 1 site in China.
Trial summary
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- EpiDural Hematoma, Traumatic Brain Injury
- What is being tested?
- MMA embolization plus medical therapy and Medical therapy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2024to Dec 2026
- 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
- Age 18 or above；
- Patients with a clear history of head trauma and confirmed acute epidural hematoma by head CT；
- Cases that the case screening committee deems suitable for conservative treatment*；
- Randomly within 6 hours after injury, and initiate treatment within 8 hours after injury；
- Epidural hematoma located on the convex surface of the brain (frontal, temporal, parietal, or occipital)；
- The patient or their representative agrees and signs an informed consent form. * The case screening committee is composed of three senior neurosurgeons, with two of them jointly deciding whether conservative treatment is possible. If there is a disagreement, the third doctor will make the final judgment. Including but not limited to the following two situations: 1. Hematoma volume<30ml, hematoma thickness<15mm, midline shift (MLS) <5mm, GCS score>8, and no focal neurological deficit; 2. If the GCS score is ≥ 13, the imaging standards can be appropriately relaxed.
Who cannot join
- Patients who require craniotomy surgery to remove hematoma；
- Bilateral acute epidural hematoma；
- Combined severe acute subdural hematoma；
- Brainstem injury；
- There are obvious brain contusions, lacerations, intracerebral hematomas, etc；
- Combined intracranial tumors and other intracranial space occupying diseases；
Show all 18Show fewer
- Severe damage to combined extracranial organs；
- mRS score > 2 before injury；
- Coagulation dysfunction (preoperative INR>1.5), abnormal platelet count and function (platelet < 80×109/L)；
- There are contraindications for cerebral angiography, such as iodine contrast agent allergy, embolization material allergy etc.；
- There may be anatomical variations that may affect the safety of MMA embolization surgery and are not suitable for endovascular embolization；
- Severe comorbidities, may prevent improvement of the condition or completion of follow-up；
- Having undergone major surgical procedures within 30 days before surgery；
- Currently participating in other clinical trials；
- Pregnant women；
- Suffering from malignant tumors with an expected lifespan of less than 1 year；
- Unable to complete follow-up as required by the protocol；
- The physician believes that the patient has other circumstances that are not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai, Shanghai Municipality, 200433
Peng-fei Yang, MD, 15921196312, 15921196312@163.com
About this study
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
Read the detailed description
This study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
All patients diagnosed with acute epidural hematoma through cranial CT will undergo neurological examination and measurement of hematoma size. For patients who meet the inclusion criteria, they will be randomly assigned 1:1 to the middle meningeal artery embolization group (intervention group) and the conservative treatment group (control group). A total of 194 subjects need to be enrolled, including 97 in the intervention group and 97 in the control group.
Primary Outcome： The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury.
*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons.
Secondary outcome：
- Changes in hematoma volume 7±2 days after injury (or at discharge)
- GCS score at 7±2 days after injury (or at discharge)；
- Hematoma volume 28±7 days after injury
- GCS score at 28±2 days after injury；
- ICU hospitalization days；
- Total hospitalization days;
- Discharge rehabilitation destination (home vs rehabilitation hospital)
- Number of re-hospitalizations；
- GOSE score at 3 months after injury
- EQ-5D scale scores at 3 months after injury；
- GOSE score at 6 months after injury
- EQ-5D scale scores at 6 months after injury
Safety outcome:
- Perioperative surgical complications (including craniotomy and neurovascular)
- All-cause mortality rate at 28 ± 7 days after injury;
- All-cause mortality rate at 3 months after injury;
- Serious adverse events (SAEs) 3 months after injury;
- All-cause mortality rate at 6 months after injury;
- Serious adverse events (SAEs) 6 months after injury.
- Conditions
- EpiDural Hematoma, Traumatic Brain Injury
- Being tested
- MMA embolization plus medical therapy, Medical therapy alone
- Keywords
- AEDH, EDH
- Medical subject headings
- Hematoma, Epidural, Spinal, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMA embolization plus medical therapyProcedure or surgery
Patients assigned to the intervention group will receive endovascular embolization treatment within 2 hours after enrollment. Patients will receive the best conservative treatment recommended by the guidelines after MMA, and conservative treatment will be the same in both groups
Medical therapy aloneDrug
Patients will receive the best conservative treatment recommended by the guidelines, and conservative treatment will be the same in both groups. Conservative treatment includes medication and general treatment. Drug therapy can be divided into hemostatic treatment, antihypertensive treatment, and symptomatic treatment. Specific local clinical diagnosis and treatment standards shall prevail or refer to corresponding clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | MMA embolization Receives: Procedure: MMA embolization plus medical therapy |
| Control group | Active comparator | Conservative treatment Receives: Drug: Medical therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury
*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons.
Measured: Within 28 days after injury
Secondary outcomes (12)
Changes in hematoma volume 7±2 days after injury (or at discharge)
Measured: 7±2 days after injury (or at discharge)
GCS score at 7±2 days after injury (or at discharge)
Measured: 7±2 days after injury (or at discharge)
Hematoma volume 28±7 days after injury
Measured: 28±7 days after injury
GCS score at 28±2 days after injury
Measured: 28±2 days after injury
ICU hospitalization days
Measured: 28±2 days after injury
Total hospitalization days
Measured: 28±2 days after injury
Discharge rehabilitation destination (home vs rehabilitation hospital)
Measured: 28±2 days after injury
Number of re-hospitalizations
Measured: 6 months after injury
GOSE score at 3 months after injury
Measured: 3 months after injury
EQ-5D scale scores at 3 months after injury
Measured: 3 months after injury
GOSE score at 6 months after injury
Measured: 6 months after injury
EQ-5D scale scores at 6 months after injury
Measured: 6 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start2 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpiDural HematomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Changzhou
- Responsible party
- Sponsor
- Investigators
- Jianimin Liu, M.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292585
- Sponsor's protocol ID
- AEDH-MT
- Acronym
- AEDH-MT
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
- ClinicalTrials.gov ID
- NCT06292585
- Acronym / sponsor ID
- AEDH-MT / AEDH-MT
- Conditions
- EpiDural Hematoma, Traumatic Brain Injury
- Keywords
- AEDH, EDH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- The First People's Hospital of Changzhou
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Mar 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.
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
Detailed description
This study is a prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
All patients diagnosed with acute epidural hematoma through cranial CT will undergo neurological examination and measurement of hematoma size. For patients who meet the inclusion criteria, they will be randomly assigned 1:1 to the middle meningeal artery embolization group (intervention group) and the conservative treatment group (control group). A total of 194 subjects need to be enrolled, including 97 in the intervention group and 97 in the control group.
Primary Outcome： The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury.
*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons.
Secondary outcome：
- Changes in hematoma volume 7±2 days after injury (or at discharge)
- GCS score at 7±2 days after injury (or at discharge)；
- Hematoma volume 28±7 days after injury
- GCS score at 28±2 days after injury；
- ICU hospitalization days；
- Total hospitalization days;
- Discharge rehabilitation destination (home vs rehabilitation hospital)
- Number of re-hospitalizations；
- GOSE score at 3 months after injury
- EQ-5D scale scores at 3 months after injury；
- GOSE score at 6 months after injury
- EQ-5D scale scores at 6 months after injury
Safety outcome:
- Perioperative surgical complications (including craniotomy and neurovascular)
- All-cause mortality rate at 28 ± 7 days after injury;
- All-cause mortality rate at 3 months after injury;
- Serious adverse events (SAEs) 3 months after injury;
- All-cause mortality rate at 6 months after injury;
- Serious adverse events (SAEs) 6 months after injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: MMA embolization plus medical therapyMMA embolization |
| Control group | Active comparator | Drug: Medical therapy aloneConservative treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or above；
- Patients with a clear history of head trauma and confirmed acute epidural hematoma by head CT；
- Cases that the case screening committee deems suitable for conservative treatment*；
- Randomly within 6 hours after injury, and initiate treatment within 8 hours after injury；
- Epidural hematoma located on the convex surface of the brain (frontal, temporal, parietal, or occipital)；
Key exclusion criteria (18 listed)
- Patients who require craniotomy surgery to remove hematoma；
- Bilateral acute epidural hematoma；
- Combined severe acute subdural hematoma；
- Brainstem injury；
- There are obvious brain contusions, lacerations, intracerebral hematomas, etc；
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 |
|---|---|---|
| MMA embolization plus medical therapyPatients assigned to the intervention group will receive endovascular embolization treatment within 2 hours after enrollment. Patients will receive the best conservative treatment recommended by the guidelines after MMA, and conservative treatment will be the same in both groups | Procedure or surgery | Intervention group |
| Medical therapy alonePatients will receive the best conservative treatment recommended by the guidelines, and conservative treatment will be the same in both groups. Conservative treatment includes medication and general treatment. Drug therapy can be divided into hemostatic treatment, antihypertensive treatment, and symptomatic treatment. Specific local clinical diagnosis and treatment standards shall prevail or refer to corresponding clinical guidelines. | Drug | Control group |
Primary outcome
The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury
Time frame: Within 28 days after injury
*This includes patients who have actually undergone surgery and those who were deemed necessary by the committee but did not undergo surgery for various reasons.
12 secondary outcomes
Changes in hematoma volume 7±2 days after injury (or at discharge)
Time frame: 7±2 days after injury (or at discharge)
GCS score at 7±2 days after injury (or at discharge)
Time frame: 7±2 days after injury (or at discharge)
Hematoma volume 28±7 days after injury
Time frame: 28±7 days after injury
GCS score at 28±2 days after injury
Time frame: 28±2 days after injury
ICU hospitalization days
Time frame: 28±2 days after injury
Total hospitalization days
Time frame: 28±2 days after injury
Discharge rehabilitation destination (home vs rehabilitation hospital)
Time frame: 28±2 days after injury
Number of re-hospitalizations
Time frame: 6 months after injury
GOSE score at 3 months after injury
Time frame: 3 months after injury
EQ-5D scale scores at 3 months after injury
Time frame: 3 months after injury
GOSE score at 6 months after injury
Time frame: 6 months after injury
EQ-5D scale scores at 6 months after injury
Time frame: 6 months after injury
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 4 Apr 2025.
- Individual participant dataSharing planned: Yes. Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
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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.
Jianimin Liu, M.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMA embolization plus medical therapy and Medical therapy alone in people with EpiDural Hematoma and Traumatic Brain Injury, run by Changhai Hospital at 1 site in China.
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 6 inclusion and 18 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 4 Apr 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 China. 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 Pengfei Yang, M.D. (86-21-31161784, 15921196312@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who require craniotomy due to the progression of epidural hematoma 7 days after injury*, and neurogenic death 28 days after injury (time frame: Within 28 days after injury). 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 4 Apr 2025.