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

Mads Hjortdal Grønhøj*, Thorbjørn Søren Rønn Jensen, Ann Kathrine Sindby, Rares Miscov, Torben Hundsholt, Birgit Debrabant, Carsten Reidies Bjarkam, Bo Bergholt, Kåre Fugleholm, Frantz Rom Poulsen

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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 h 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 the time of admission or no later than 6 h after surgery. Each patient is randomized to either 6, 12, or 24 h 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 the 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, 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: ISRCTN Registry 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.

OriginalsprogEngelsk
Artikelnummer213
TidsskriftTrials
Vol/bind23
Antal sider14
ISSN1745-6215
DOI
StatusUdgivet - 14. mar. 2022

Bibliografisk note

Funding Information:
We thank Claire Gudex, Department of Clinical Research, University of Southern Denmark, for proofreading the manuscript. Biological material is stored in OPEN?Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark: http://www.sdu.dk/ki/open MHG was involved in the design of the trial, trial setup, and trial coordination; wrote the study protocol; and drafted the manuscript. TSRJ was involved in the trial design, trial setup, and trial coordination. AKS, RM, TH, CRB, and BB were involved in the trial setup. BD designed the statistical analysis for the trial and drafted the corresponding part of the manuscript. KF was involved in the trial design and trial setup. FRP was involved in the trial design, trial setup, and drafting of the study protocol. All authors have read and approved the final manuscript. The research is funded by the Danish healthcare system. MHG was in July 2021 granted a 20% post-doc stipend by the Region of Southern Denmark. TSRJ is funded by Rigshospitalet?s research foundation as part of his Ph.D. project. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. The corresponding author will be responsible for providing access to research data requested by third parties as freely and timely as possible, unless access to the data is restricted by a legal obligation (e.g., non-disclosure agreement), intellectual property protection, ethical approval requirements, ethical or security reasons, or other legitimate reasons.

Funding Information:
The research is funded by the Danish healthcare system. MHG was in July 2021 granted a 20% post-doc stipend by the Region of Southern Denmark. TSRJ is funded by Rigshospitalet’s research foundation as part of his Ph.D. project.

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