Short summary

SUPERDURA is a multicenter randomized non-inferiority trial encompassing all neurosurgical units in Denmark. Examining the optimal drain location after single burr hole evacuation of a chronic subdural hematoma. 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.

Rationale

Background / The main treatment of chronic subdural hematoma (CSDH) is neurosurgical evacuation with subsequent drainage. However, consensus on the optimal drain modality and placement is lacking. Aim / To examine whether 24-hour active subperiosteal drainage is non-inferior to 24-hour passive subdural drainage after single burr hole evacuation of a symptomatic CSDH.

Description of the cohort

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. 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 be 2 years.

Data and biological material

Questionaire data, data from patient journal, CT and MR scans.

Collaborating researchers and departments

Department of Neurosurgery, Aarhus University Hospital

• Anders Korshøj
• Mette Haldrup

Department of Neurosurgery, Odense University Hospital

• Frantz Rom Poulsen
• Mads Grønhøj

Department of Neurosurgery, Rigshospitalet Copenhagen

• Thorbjørn Rønn Jensen
• Kåre Fugleholm
• Anders Schack

Department of Neurosurgery, Aalborg University Hospital

• Jacob Holmen Terkelsen
• Rares Miscov

Publications associated with the project

Jensen TSR, Andersen-Ranberg N, Poulsen FR, Bergholt B, Hundsholt T, Fugleholm K. The Danish Chronic Subdural Hematoma Study-Risk Factors for Second Recurrence. World Neurosurg. 2022 Dec;168:e178-e186. doi: 10.1016/j.wneu.2022.09.072. Epub 2022 Sep 21. PMID: 36152937.

Jensen TSR, Haldrup M, Hjortdal Grønhøj M, Miscov R, Larsen CC, Debrabant B, Poulsen FR, Bergholt B, Hundsholt T, Bjarkam CR, Fugleholm K. National randomized clinical trial on subdural drainage time after chronic subdural hematoma evacuation. J Neurosurg. 2021 Dec 31;137(3):799-806. doi: 10.3171/2021.10.JNS211608. PMID: 34972091.

Grønhøj MH, Jensen TSR, Sindby AK, Miscov R, Hundsholt T, Debrabant B, Bjarkam CR, Bergholt B, Fugleholm K, Poulsen FR. Postoperative drainage for 6, 12, or 24 h after burr-hole evacuation of chronic subdural hematoma in symptomatic patients (DRAIN-TIME 2): study protocol for a nationwide randomized controlled trial. Trials. 2022 Mar 14;23(1):213. doi: 10.1186/s13063-022-06150-x. PMID: 35287694; PMCID: PMC8919549.