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

Launched by AALBORG UNIVERSITY HOSPITAL · Sep 28, 2024

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ClinConnect Summary

This clinical trial is looking at the best way to drain a chronic subdural hematoma (CSDH), which is a collection of blood that forms on the brain’s surface. The trial will compare two drainage methods after a specific type of surgery called a burr hole evacuation. One method is called "active subperiosteal drainage," where the drain is actively helping to remove fluid, and the other is "passive subdural drainage," where the fluid drains naturally. Researchers want to see if both methods are equally effective in preventing complications like death or the need for more surgery within 90 days.

To participate in the trial, you need to be an adult (18 years or older) with symptoms of a unilateral (one-sided) CSDH confirmed by brain imaging, and you must be admitted for a burr hole evacuation. However, some individuals may not be eligible, such as those who cannot provide consent, have certain brain abnormalities, or have had previous brain surgeries. If you join the trial, you will be randomly assigned to one of the two drainage methods, and your progress will be monitored for three months after the surgery to check for any complications or recurrence of the hematoma. The study aims to include around 598 patients over the next 2-3 years across various hospitals in Denmark.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients (≥ 18 years).
• • Patients with symptomatic CSDH confirmed on brain CT- or magnetic resonance imaging (MRI), admitted to a Danish neurosurgical department for surgical treatment.
• • Patients undergoing a single burr-hole evacuation.
• • Informed written and oral consent is taken prior to surgery.
• Exclusion Criteria:
• • Patients who are mentally incapacitated
• • Patients with known abnormalities in their cerebrospinal fluid (protein and glucose levels, cell count, and type)
• • Patients with changes or abnormalities in their normal cerebrospinal fluid dynamics, e.g., obstructive hydrocephalus, normal pressure hydrocephalus, intracranial hypotension, and ventricular peritoneal shunt.
• • Patients with additional/previously intracranial pathology that requires/has required neurosurgical treatment (e.g., brain tumor, vascular malformation, abscess).
• • Patients with recurrent CSDH or with previous craniotomy or other transcranial surgery (for any reason)
• • Patients unable to give consent prior to surgery