Management of CSDH With or Without EMMA- a Randomized Control Trial

Launched by UNIVERSITY OF MANITOBA · Feb 10, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Management of CSDH With or Without EMMA," is looking at how to treat a condition known as chronic subdural hematoma (CSDH), which is a collection of blood on the brain's surface that can cause symptoms like headaches, confusion, or weakness. The study compares two groups of patients: one group will receive standard treatments, such as surgery or medications, while the other group will receive the same treatments plus a special procedure called embolization of the middle meningeal artery (EMMA). This trial aims to see if adding the EMMA procedure can reduce the chances of CSDH coming back after treatment.

To participate in this trial, patients should be between the ages of 65 and 74 and have specific symptoms linked to CSDH, along with a certain size of the hematoma seen on a CT scan. They should also be able to provide consent for the study. If selected, participants can expect close monitoring and follow-up as researchers gather information on their treatment outcomes. It’s important to note that some patients may not be eligible if they have certain health issues or if their condition is linked to other serious medical problems. This study is currently recruiting participants, and all genders are welcome to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Modified Rankin Scale of ≤2 at baseline
• • 2. Patients requiring surgery or has at least 10 mm of CSDH on CT head and has one or more symptoms attributable to CSDH, including headache, cognitive impairment, ataxia, seizure, focal neurologic deficit, or decreased consciousness.
• • 3. CT Angiogram of head and neck which favors vascular access for EMMA and lacks dangerous anatomic variations.
• Exclusion Criteria:
• • 1. If informed consent can not be obtained from the patients or their substitute decision makers.
• • 2. CT Angiogram showing dangerous communication between middle meningeal artery and branches of internal carotid arteries.
• • 3. Contraindication to the embolization procedure such as severe renal dysfunction, or pregnancy
• • 4. Life expectancy \< 6 months.
• • 5. Known allergy to embolic agent
• • 6. Acute subdural hematoma with homogenous hyperdensity on CT scan.
• • 7. Secondary CSDH that may likely be due to the underlying condition such as a vascular lesion, brain tumor, arachnoid cyst, spontaneous intracranial hypotension or prior craniotomy.