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

RecruitingNAAges 18 Years - anyAllAalborg University Hospital
NCT06621407 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Chronic subdural hematoma (CSDH) is a common disease. The main treatment is neurosurgical evacuation and subsequent hematoma drainage. However, consensus on the optimal drain placement site, and whether the drainage should be active or passive, is lacking. The aim of the current study is to test the hypothesis that 24 hours active subperiosteal drainage is non-inferior to 24 hours passive subdural drainage after single burr hole evacuation of a unilateral CSDH. The study is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities, and other known brain pathologies will be excluded. Pa

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📋 Eligibility rules (as published)
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
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What it tests

  • 24 hours active subperiostal drainage
  • 24 hours passive subdural drainage
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Where

4 sites
Department of Neurosurgery, Aalborg University Hospital
Aalborg, Denmark
Department of Neurosurgery, Aarhus University Hospital
Aarhus, Denmark
Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Department of Neurosurgery, Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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