Status:
RECRUITING
A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma
Lead Sponsor:
Aalborg University Hospital
Collaborating Sponsors:
Odense University Hospital
Rigshospitalet, Denmark
Conditions:
Chronic Subdural Hematoma
Surgical Procedures, Operative
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 wheth...
Detailed Description
The incidence of symptomatic chronic subdural hematoma (CSDH) is sharply on the rise due to an ageing population, and population risk factors such as alcohol misuse, falls, and use of anticoagulants a...
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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT06621407
Start Date
September 1 2025
End Date
November 1 2027
Last Update
November 25 2025
Active Locations (4)
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1
Department of Neurosurgery, Aalborg University Hospital
Aalborg, Denmark, 9000
2
Department of Neurosurgery, Aarhus University Hospital
Aarhus, Denmark, 8000
3
Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, 2100
4
Department of Neurosurgery, Odense University Hospital
Odense, Denmark, 5100