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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Page 1 of 1 (4 locations)

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