Best drainage method after burr hole evacuation for chronic subdural hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.