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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Changhai hospital
RECRUITING
Shanghai
Contact Information
Primary
Pengfei Yang, M.D.
15921196312@163.com
86-21-31161784
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 194
Treatments
Experimental: Intervention group
MMA embolization
Active_comparator: Control group
Conservative treatment
Related Therapeutic Areas
Sponsors
Collaborators: The First People's Hospital of Changzhou
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov

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