Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA)

Launched by JUAN M. RAMOS ACEVEDO · Jun 13, 2024

Keywords

ClinConnect Summary

The Puerto Rico Embolization of the Middle Meningeal Artery for the Treatment of Chronic Subdural Hematoma Trial (PREMMA) is a study aimed at finding out the best way to treat chronic subdural hematomas, which are collections of blood on the brain's surface that can cause symptoms like headaches or confusion. The trial will compare two treatment methods: one involves a procedure called embolization, which blocks the blood vessels supplying the hematoma, and the other is a more traditional surgical approach where the hematoma is removed through small openings in the skull. Researchers will look at how often patients need further surgery and how their neurological health improves with each treatment.

To be eligible for this trial, participants must be at least 21 years old, speak and understand either Spanish or English, and live in Puerto Rico. They should also have a specific type of chronic subdural hematoma confirmed by imaging tests and meet certain health criteria. Participants can expect to receive either of the two treatments and will be followed closely to assess their health outcomes. It's important to note that individuals with certain health issues, such as other brain injuries or specific medical conditions, may not be able to participate. If you or a loved one is considering this trial, it could provide valuable information about treatment options for chronic subdural hematomas.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 21
• • Speak and understand Spanish or English
• • Resident of Puerto Rico
• • Glasgow coma scale ≥ 14/15
• • Presence of cSDH on non-contrast computed tomography (NCCT) or magnetic resonance imaging (MRI)
• • Neurological indication for treatment of cSDH (Markwalder scale ≤ 2)
• • No previous surgical or endovascular treatment for symptomatic cSDH
• • Signed informed consent for participation in the study by the patient or legally authorized representative
• Exclusion Criteria:
• • Acute subdural hematoma
• • Focal, non-hemispheric localization of cSDH
• • Evidence of other lesions associated with cSDH, such as neoplasms, vascular lesions, or additional epidural, subarachnoid, or parenchymal hemorrhage on non-contrast computed tomography or magnetic resonance imaging
• • Imaging evidence of skull fracture over the subdural hematoma
• • Presence of any cerebrospinal fluid (CSF) shunt
• • Imaging evidence of midline shift ≥ 10 mm
• • Imaging evidence of basal cistern effacement
• • Imaging evidence of dilatation of lateral ventricles
• • Imaging evidence of uncal herniation
• • Modified Rankin scale ≥ 3 before developing symptoms associated with cSDH
• • Contraindications for angiography (i.e., complex anatomy or kidney failure)
• • Comorbidity making follow-up impossible
• • Pregnancy
• • Vulnerable patients, including homeless patients, incarcerated patients, and mentally ill patients without appropriate medical decision-making proxies that the physician believes are incapable of appropriately assessing the risks of the procedure
• • Absence of medical insurance