Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)
NCT Number: NCT06466733
Acronym: PREMMA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Subdural Hematoma
Interventions: PROCEDURE: Embolization of the middle meningeal artery|PROCEDURE: Surgical Evacuation via burr hole or craniotomy
Sponsor: Juan M. Ramos Acevedo
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 658
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2031-07

Summary:
Puerto Rico Embolization of the Middle Meningeal Artery (PREMMA) trial is a multi-center, parallel, prospective, superiority, randomized controlled trial with concealed allocation comparing reoperation rates and neurological outcomes in patients with chronic subdural hematoma that receive treatment via embolization of the middle meningeal artery versus surgical evacuation via burr hole trephination or craniotomy.

Primary Outcome Measures: Reoperation, Number of patients requiring reoperation due to recurrent chronic subdural hematoma., 3 months, 6 months, and 12 months
Secondary Outcome Measures: Modified Rankin Scale (mRS), The modified Rankin Scale (mRS) will assess neurological disability. The scale comprises seven levels, from 0 to 6, with higher scores indicating greater disability, and 6 indicating death., Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, and 12 months|Glasgow Coma Scale (GCS), The Glasgow coma scale (GCS) will assess consciousness level. GCS score can range from 3 (completely unresponsive) to 15 (completely alert and oriented)., Pre-operative, 24 hours, 2 weeks|Visual Analog Scale (VAS), The visual analog scale (VAS) will assess pain levels. VAS represents the severity of pain from 0 "no pain" to 10 "very severe pain.", Pre-operative, 24 hours, 2 weeks, 1.5 months, 3 months, 6 months, 12 months|Quality of life (EQ-5D-5L), Will be measured with the EuroQol 5 dimensions and 5 levels (EQ-5D-5L) grading scale., Pre-operative, 2 weeks, 1.5 months, 3 months, 6 months, 12 months|Radiological outcomes, Will be measured by routine computed tomography compared with pre-operative images., Pre-operative, 24 hours, 3 months, 6 months, 12 months|Technical success of embolization of the middle meningeal artery (eMMA), The rate of unsuccessful eMMA due to technical failure or anatomical issues will be recorded., 24 hours|Procedure-related complications, Any life-threatening event from enrollment to discharge will be recorded., 24 hours, 2 weeks, 1.5 months, 3 months|Adverse events, Any unintentional injury or complication involving a prolonged stay, disability at discharge, or death caused by healthcare management, not the underlying disease, will be recorded., 24 hours, 2 weeks, 1.5 months, 3 months|Post-operative morbidity, All surgical and/or medical complications that occur., 24 hours, 2 weeks, 1.5 months, 3 months|Mortality, The number of participants among the total number of deaths., 24 hours, 2 weeks, 30 days, 1.5 months, 3 months, 6 months, 12 months|Length of stay, The patient's hospitalization period., From date of randomization until the date of discharge or date of death from any cause while patient is in hospital, whichever came first, assessed up to 90 days