Endovascular vs Conservative Treatment in Patients With Chronic Subdural Hematomas and Mild Symptoms

Launched by OSPEDALE POLICLINICO SAN MARTINO · Feb 20, 2024

Keywords

ClinConnect Summary

This clinical trial, called the Embotrial-1 study, is looking at two different ways to treat patients with chronic subdural hematomas (cSDH), which are collections of blood on the brain's surface that can cause mild symptoms. The trial will compare a procedure called MMA embolization, where a doctor blocks certain blood vessels to reduce the hematoma, with conservative treatment, which involves careful monitoring and best medical care without surgery. The goal is to see if MMA embolization is more effective than just managing the condition with medication and observation.

To take part in this study, participants should be between the ages of 65 and 74, have mild symptoms without significant neurological problems, and have a specific type of cSDH that meets certain size criteria. They must also be able to attend follow-up visits. However, people with certain conditions, like recent brain bleeds or serious health problems, won't be eligible. If you join the trial, you'll be randomly assigned to one of the two treatment groups and will be monitored closely to see how well the treatment works. This trial is not yet recruiting participants, but it aims to help improve treatment options for cSDH in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • No neurological deficits (Markwalder score ≤1);
• • Unilateral or bilateral cSDH;
• • Subdural Hematoma width ≤ 20 mm; midline shift ≤ 7mm;
• • Independent functional status with mRS score ≤ 2 prior to symptom onset;
• • Likely compliance of the participant in attending follow-up examination.
• Exclusion Criteria:
• • Radiological evidence of an acute or subacute subdural hematoma, subarachnoid hemorrhage, intracerebral hematoma or epidural hematoma;
• • Contraindications to angiography (end stage chronic renal disease, any sign of anatomical variations that could make MMA embolization unsafe, pregnancy);
• • Life expectancy \< 1 year;
• • Patients with any kind of ventricular derivation catheter.