Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)-protocol.
Trials
; 24(1): 586, 2023 Sep 14.
Article
in En
| MEDLINE
| ID: mdl-37710274
ABSTRACT
BACKGROUND:
The conventional treatments for non-acute subdural hematoma (SDH) are facing the challenge of high hematoma recurrence and progression. A novel treatment of middle meningeal artery (MMA) embolization showed the potential role in decreasing the recurrence and progression rate of SDH compared to conventional treatments in multiple cohort studies. A randomized controlled trial is warranted to determine the effectiveness and safety of MMA embolization for non-acute hematoma and whether MMA embolization is superior to conventional treatments to lower the symptomatic recurrence and progression rate of non-acute SDH.METHODS:
This is an investigator-initiated, multi-center, prospective, open-label parallel group trial with blinded outcome assessment (PROBE design) assessing superiority of MMA embolization compared to conventional treatments. A total of 722 patients are planned to be randomized 11 to receive MMA embolization (intervention) or conventional treatments (control). The primary outcome is the symptomatic SDH recurrence/progression rate within 90 ± 14 days post-randomization.DISCUSSION:
This trial will clarify whether MMA embolization could reduce the recurrence or progression rate of symptomatic non-acute SDH compared to conventional treatment. TRIAL REGISTRATION ClinicalTrials.gov. Identifier NCT04700345, Registered on 7 January 2021.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
East Asian People
/
Meningeal Arteries
Type of study:
Clinical_trials
/
Guideline
/
Observational_studies
Limits:
Humans
Language:
En
Journal:
Trials
Year:
2023
Document type:
Article