Active 24 Hours Subperiostal vs. Passive Subdural Drainage After Burr Hole Evacuation of Chronic Subdural Hematoma A Nationwide Randomized Trial

What this Trial Is About

Chronic subdural hematoma (CSDH) is a common condition often treated by neurosurgical evacuation and drainage of the hematoma. This research aims to compare two drainage methods after surgery: 24 hours of active subperiosteal drainage versus 24 hours of passive subdural drainage. The study is a nationwide, randomized clinical trial conducted across all neurosurgical units in Denmark to evaluate if active drainage is not worse than passive drainage in terms of safety and recurrence. Participants will be adults with symptomatic unilateral CSDH undergoing single burr hole evacuation. Before surgery, patients will be randomly assigned to receive either 24 hours of active subperiosteal drainage or 24 hours of passive subdural drainage. Both drainage methods are already in use, but a direct comparison has not been done. The trial will monitor patients for 90 days post-surgery to assess outcomes. During the study, participants will be evaluated for mortality and recurrence of CSDH requiring reoperation within 90 days. Other assessments include complications related to surgery, length of hospital stay, and functional outcomes measured by the simplified modified Rankin scale. The study uses a double-blind design for patients and statisticians and plans to enroll 354 participants over approximately two years.

A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma