Active 24 Hours Subperiostal vs. 24 Hours Passive Subdural Drainage Following Burr Hole Evacuation of Chronic Subdural Hematoma (the SUPERDURA Trial) - Protocol for a Nationwide Randomized Clinical Non-inferiority Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Department of Neurosurgery, Aalborg University Hospital
RECRUITING
Aalborg
Department of Neurosurgery, Aarhus University Hospital
RECRUITING
Aarhus
Department of Neurosurgery, Copenhagen University Hospital Rigshospitalet
RECRUITING
Copenhagen
Department of Neurosurgery, Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Carsten R Bjarkam, Professor, Ph.D., DMSc.
c.bjarkam@rn.dk
45+ 211671
Backup
Rares Miscov, MD
ram@rn.dk
45+ 27831360
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-11
Participants
Target number of participants: 354
Treatments
Experimental: 24 hours active subperiostal drainage
24 hours active subperiostal drainage after single burr hole evacuation of a chronic subdural hematoma
Experimental: 24 hours passive subdural drainage
24 hours passive subdural drainage after single burr hole evacuation of a chronic subdural hematoma
Sponsors
Collaborators: Odense University Hospital, Aarhus University Hospital, Rigshospitalet, Denmark
Leads: Aalborg University Hospital

This content was sourced from clinicaltrials.gov