Condition: Chronic Subdural Hematoma · Surgical Procedures, Operative · Recurrence · Sponsor: Aalborg University Hospital
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 …
This description comes directly from the study's public registry record.
Carsten R Bjarkam, Professor, Ph.D., DMSc. · 45+ 211671 · c.bjarkam@rn.dk
Rares Miscov, MD · 45+ 27831360 · ram@rn.dk
Always discuss trial participation with your own doctor first.
| 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 |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06621407