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).
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.
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).
Parallel
24 hours active subperiostal drainage
Procedure/Surgery24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma
24 hours passive subdural drainage
Procedure/Surgery24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma
Composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period
The primary outcome measure is a composite outcome of 90-day mortality and recurrent CSDH on the same side as the primary operation requiring reoperation within the 90-day observation period. Recurrent CSDH is defined as a re-accumulation of the previously treated CSDH requiring ipsilateral or bilateral reoperation following symptom improvement after the first operation. For both unilateral and bilateral hematomas, recurrence will be considered as one reoperation.
90-day simplified modified Rankin scale
The scores on the simplified modified Rankin scale will be assessed with the use of the simplified mRS validated questionnaire, which will be completed over the telephone by the patients or next of kin at 90 (80-100) days after surgery. The results will be dichotomized and analyzed with 0-2 as favourable clinical outcome and 3-6 as unfavourable outcome.
90-day serious adverse events (SAE)
Serious adverse events (SAE) necessitating new hospitalization in the 90 days postoperative period
Complications related to surgery
Complications related to surgery encompasing intracerebral hemorrhage due to misplaced drains, acute subdural hematoma, tension pneumocephalus, wound infection, drain seepage, subperiostal hematoma, and seizures.
Postoperative adverse events during the admission
Postoperative adverse events during the admission emcompassing thromboembolic events and/or infections.
Use of antithrombotics
Use of antithrombotic (its preoperative time of cessation, and its postoperative time of restart). Related to the primary outcome.
Time to surgery
Time to surgery (split between median time of population) related to the primary outcome
Unilateral versus bilateral CSDH
Unilateral versus bilateral CSDH related to the primary outcome
Recurrence rate per hematoma side
Symptomatic CSDH recurrence requiring operation counted pr hematoma side
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Aalborg University Hospital
Lead sponsor
Odense University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Aarhus University Hospital
Collaborator
