An interventional study of MMA embolization plus medical therapy and Medical therapy alone in EpiDural Hematoma and Traumatic Brain Injury, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
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：
Safety outcome:
20 studies on the registry are indexed under Hematoma, Epidural, Spinal; 5 are open to participants now.
This study's planned enrollment of 194 is above the median of 151 across 11 interventional studies indexed under Hematoma, Epidural, Spinal.
Browse Hematoma, Epidural, Spinal studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria：
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMA embolization
Procedure: MMA embolization plus medical therapy
Conservative treatment
Drug: Medical therapy alone
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
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.
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.
Time frame: Within 28 days after injury
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
Perioperative surgical complications (including craniotomy and neurovascular)
Time frame: Perioperative period
All-cause mortality rate at 28 ± 7 days after injury
Time frame: 28 ± 7 days after injury
All-cause mortality rate at 3 months after injury
Time frame: 3 months after injury
Serious adverse events (SAEs) 3 months after injury
Time frame: 3 months after injury
All-cause mortality rate at 6 months after injury
Time frame: 6 months after injury
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data sharing will be available from 12 months after the publication of the main results.
Access criteria: The data sharing will be only for the purposes of health and medical research and within the constraints of the consent under which the data were originally gathered. The Custodian of the Collection will not consider any Proposals for data sharing that unblind, or potentially unblind, randomised comparisons in active / ongoing trials. Requesters should be employees of a recognised academic institution, health service organisation, commercial research organisation or from the pharmaceutical industry. Requesters must have experience in medical research. Requesters must be able to demonstrate through their peer review publications in the area of interest their ability to carry out the proposed use of the requested dataset from a Collection. The Requesters must not have a conflict of interest that may potentially influence their interpretation of any analyses.
Data sharing details ↗ · www.ocin.org.cn
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jun 2026, 21 months after the start.
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