Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization:

Status Not yet recruiting

Clinical Trial Summary

A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.

Clinical Trial 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 168 subjects need to be enrolled, including 84 in the intervention group and 84 in the control group. Primary Outcome： The proportion of patients who die within 72 hours after injury or progress to require craniotomy due to epidural hematoma. Indications for craniotomy surgery：The hematoma volume of acute epidural hematoma is greater than 30ml; Hematoma thickness>15mm; Middle line displacement>5mm; GCS<9 points. Meet any criteria that are deemed to have reached the main outcome. Secondary outcome： 1. Changes in hematoma volume 7±2 days after injury (or at discharge) 2. GCS score at 7±2 days after injury (or at discharge)； 3. ICU hospitalization days； 4. Success rate of target vessel embolization (MMA main and branch vessels) in DSA imaging; 5. Complications related to interventional surgery; 6. Changes in hematoma volume 30±7 days after injury 7. GCS score at 30±7 days after injury； 8. GOSE score at 6 months after injury 9. All-cause mortality rate at 6 months after injury； 10. EQ-5D scale scores at 6 months after injury； 11. Serious adverse events within 6 months after injury (SAE)； 12. GOSE score at 1 year after injury 13. All-cause mortality rate at 1 year after injury； 14. EQ-5D scale scores at 1 year after injury ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06292585
Study type	Interventional
Source	Changhai Hospital
Contact	Pengfei Yang, M.D.
Phone	86-21-31161784
Email	15921196312@163.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2024
Completion date	December 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms