Best drainage method after burr hole evacuation for chronic subdural hematoma
Active 24 Hours Subperiostal vs. 24 Hours Passive Subdural Drainage Following Burr Hole Evacuation of Chronic Subdural Hematoma (the SUPERDURA Trial) - Protocol for a Nationwide Randomized Clinical Non-inferiority Trial
This trial tests whether 24 hours of active subperiosteal drainage works as well as 24 hours of passive subdural drainage for adults having a single burr‑hole evacuation of a symptomatic chronic subdural hematoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 354 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT06621407 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized non‑inferiority trial run across all Danish neurosurgical units comparing two 24‑hour drainage strategies after single burr‑hole evacuation of symptomatic chronic subdural hematoma. Eligible adult patients able to give informed consent are randomized to either active subperiosteal drainage or passive subdural drainage, with bilateral cases recorded and treated similarly on both sides. Key exclusions include recurrent CSDH, known cerebrospinal fluid abnormalities, prior intracranial pathology requiring surgery, and inability to consent. The trial aims to standardize practice by directly comparing outcomes such as recurrence and mortality between the two drainage methods.
Who should consider this trial
Good fit: Adults (≥18) with symptomatic chronic subdural hematoma admitted to a participating Danish neurosurgical unit for single burr‑hole evacuation who can give informed consent are ideal candidates.
Not a fit: Patients with recurrent CSDH, known CSF abnormalities, prior intracranial surgery or other major brain pathology, or those unable to provide informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could simplify and standardize postoperative drainage practice and potentially reduce recurrence or complications after evacuation.
How similar studies have performed: Previous smaller or single‑center studies have compared drain placement and drainage methods with mixed or inconclusive results, so a national randomized trial is being done to provide definitive evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 3 other locations
- Department of Neurosurgery, Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Department of Neurosurgery, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Department of Neurosurgery, Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Carsten R Bjarkam, Professor, Ph.D., DMSc.
- Email: c.bjarkam@rn.dk
- Phone: 45+ 211671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.