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| Name | Class |
|---|---|
| The First People's Hospital of Changzhou | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | MMA embolization |
|
| Control group | Active Comparator | Conservative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMA embolization plus medical therapy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 28 days after injury |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in hematoma volume 7±2 days after injury (or at discharge) | 7±2 days after injury (or at discharge) | |
| GCS score at 7±2 days after injury (or at discharge) | 7±2 days after injury (or at discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative surgical complications (including craniotomy and neurovascular) | Perioperative period | |
| All-cause mortality rate at 28 ± 7 days after injury | 28 ± 7 days after injury | |
Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengfei Yang, M.D. | Contact | 86-21-31161784 | 15921196312@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianimin Liu, M.D. | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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.
Data sharing will be available from 12 months after the publication of the main results.
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| ID | Term |
|---|---|
| D046748 | Hematoma, Epidural, Spinal |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Medical therapy alone | Drug | 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. |
|
| Hematoma volume 28±7 days after injury | 28±7 days after injury |
| GCS score at 28±2 days after injury | 28±2 days after injury |
| ICU hospitalization days | 28±2 days after injury |
| Total hospitalization days | 28±2 days after injury |
| Discharge rehabilitation destination (home vs rehabilitation hospital) | 28±2 days after injury |
| Number of re-hospitalizations | 6 months after injury |
| GOSE score at 3 months after injury | 3 months after injury |
| EQ-5D scale scores at 3 months after injury | 3 months after injury |
| GOSE score at 6 months after injury | 6 months after injury |
| EQ-5D scale scores at 6 months after injury | 6 months after injury |
| All-cause mortality rate at 3 months after injury |
| 3 months after injury |
| Serious adverse events (SAEs) 3 months after injury | 3 months after injury |
| All-cause mortality rate at 6 months after injury | 6 months after injury |
| D001930 |
| Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |