Postoperative Drainage for 6, 12, or 24 Hours After Burr-Hole Evacuation of Chronic Subdural Hematoma in Symptomatic Patients (DRAIN-TIME 2): Study Protocol for a Nationwide Randomized Controlled Trial

Abstract Background: Chronic subdural hematoma (CSDH) is a common acute or subacute neurosurgical condition, typically treated by burr-hole evacuation and drainage. Recurrent CSDH occurs in 5-20 % of cases and requires reoperation in symptomatic patients, sometimes repeatedly. Postoperative subdural drainage of maximal 48 hours is effective in reducing recurrent hematomas. However, the shortest possible drainage time without increasing the recurrence rate is unknown.Methods: DRAIN-TIME 2 is a Danish multi-center, randomized controlled trial of postoperative drainage time including all four neurosurgical departments in Denmark. Both incapacitated and mentally competent patients are enrolled. Patients older than 18 years, free of other intracranial pathologies or history of previous brain surgery, are recruited at time of admission or no later than 6 hours after surgery. Each patient is randomized to either 6, 12, or 24 hours of passive subdural drainage following single burr-hole evacuation of a CSDH. Mentally competent patients are asked to complete the SF-36 questionnaire. The primary endpoint is CSDH recurrence rate at 90 days. Secondary outcome measures include SF-36 at 90 days, length of hospital stay, drain-related complications, and complications related to immobilization and mortality.Discussion: This multi-center trial will provide evidence regarding shortest possible drainage time without increasing the recurrence rate. The potential impact of this study is significant as we believe that a shorter drainage period may be associated with fewer drain-related complications, faster mobilization, fewer complications related to immobilization, and shorter hospital stays—thus reducing the overall health service burden from this condition. The expected benefits for patients’ lives and health costs will increase as the CSDH patient population grows.Trial registration: ISRCTN15186366. https://doi.org/10.1186/ISRCTN15186366. Registered in December 2020 and updated in October 2021.This protocol was developed in accordance with the SPIRIT checklist and by use of the structured study protocol template provided by BMC Trials.