Acute EpiDural Hematoma Treated With Middle Meningeal Artery Embolization: a Randomized Trial (AEDH-MT)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
A prospective, multicenter, randomized controlled, open-label, blinded endpoint evaluation study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
Patients who require craniotomy surgery to remove hematoma；
Bilateral acute epidural hematoma；
Combined severe acute subdural hematoma；
Brainstem injury；
Trial design
Design model
Parallel
Treatments tested in this trial
MMA embolization plus medical therapy
Procedure/SurgeryPatients 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 alone
DrugPatients 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.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 injurySecondary outcomes
1
Changes in hematoma volume 7±2 days after injury (or at discharge)
Time frame
7±2 days after injury (or at discharge)2
GCS score at 7±2 days after injury (or at discharge)
Time frame
7±2 days after injury (or at discharge)3
Hematoma volume 28±7 days after injury
Time frame
28±7 days after injury4
GCS score at 28±2 days after injury
Time frame
28±2 days after injuryOther outcomes
1
Perioperative surgical complications (including craniotomy and neurovascular)
Time frame
Perioperative period2
All-cause mortality rate at 28 ± 7 days after injury
Time frame
28 ± 7 days after injury3
All-cause mortality rate at 3 months after injury
Time frame
3 months after injury4
Serious adverse events (SAEs) 3 months after injury
Time frame
3 months after injurySponsors and contacts
Click on the lead sponsor to view all of their trials.
Changhai Hospital
Lead sponsor
The First People's Hospital of Changzhou
Collaborator
Source ClinicalTrials.gov