NCT06621407 A National Study Examining the Most Effective Drainage Method After Burr Hole Evacuation of Chronic Subdural Hematoma
| NCT ID | NCT06621407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University Hospital |
| Condition | Chronic Subdural Hematoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 354 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 354 participants in total. It began in 2025-09-01 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical hematoma evacuation patients will be randomized to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score (smRSq), and complications related to surgery or occurring during admission, including intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiosteal hematoma, thromboembolic events, infections and seizures. Sample size simulations of non-inferiority with a threshold of 7% increased relative risk show that a total of 354 participants will be required to demonstrate a relative risk reduction of recurrent CSDH and mortality of 30% for the cohort receiving active subperiosteal drainage given a stable power above 80% with an alpha of 5%. The study inclusion period is estimated to last 2 years. Ethics approval for inclusion of competent patients has been obtained (N-20240009).
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
Contact & Investigator
Carsten R Bjarkam, MD, PhD, DMSc
STUDY DIRECTOR
Department of Neurosurgery, Aalborg University Hospital, Denmark
Frequently Asked Questions
Who can join the NCT06621407 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06621407 currently recruiting?
Yes, NCT06621407 is actively recruiting participants. Contact the research team at c.bjarkam@rn.dk for enrollment information.
Where is the NCT06621407 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT06621407 clinical trial?
NCT06621407 is sponsored by Aalborg University Hospital. The principal investigator is Carsten R Bjarkam, MD, PhD, DMSc at Department of Neurosurgery, Aalborg University Hospital, Denmark. The trial plans to enroll 354 participants.