Staff specialist, MD, Ph.D. Mads Hjortdal Grønhøj Department of neurosurgery, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Inkluderede deltagere med prøver
Post operative drainage in 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.
CSDH patients are after burr-hole evacuation randomized to post operative drainage in 6, 12 or 24 hours.
This study 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, less complications related to immobilization and shorter hospital stays.
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 neccessitating 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.
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 fill out SF-36. The primary endpoint is 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.
Description of the cohort
Patients admitted to department of neurosurgery suffering a chronic subdural hematoma (CSDH)