OBJECTIVE Timing of mobilization after chronic subdural hematoma (cSDH) surgery is highly heterogeneous among neurosurgical centers. Past studies have suggested that early mobilization may reduce medical complications without increasing recurrence, but evidence remains scarce. The purpose of this study was to compare an early mobilization protocol with a 48-hour bed rest practice, with a focus on the occurrence of medical complications. METHODS The GET-UP Trial is a prospective, randomized, unicentric, open-label study with an intention-to-treat primary analysis designed to evaluate the impact of an early mobilization protocol after burr hole craniostomy for cSDH on the occurrence of medical complications and functional outcomes. A total of 208 patients were recruited and randomly assigned to either an early mobilization group where they began head-of-bed elevation within the first 12 hours after surgery and proceeded to sedestation, orthostatism, and/or walking as rapidly as tolerated, or to a bed rest group where they remained recumbent with a head-of-bed angle inferior to 30° for 48 hours after surgery. The primary outcome was the occurrence of a medical complication (defined as either an infection, seizure, or thrombotic event) after surgery and until clinical discharge. Secondary outcomes included length of stay measured from randomization to clinical discharge, surgical hematoma recurrence at clinical discharge and 1 month after surgery, and Glasgow Outcome Scale–Extended (GOSE) assessment at clinical discharge and 1 month after surgery. RESULTS A total of 104 patients were randomly assigned to each group. No significant baseline clinical differences were observed before randomization. The primary outcome occurred in 36 (34.6%) patients included in the bed rest group and 20 (19.2%) in the early mobilization group (p = 0.012). At 1 month after surgery, a favorable functional outcome (defined as GOSE score ≥ 5) was observed in 75 (72.1%) patients in the bed rest group and 85 (81.7%) in the early mobilization group (p = 0.100). Surgical recurrence occurred in 5 (4.8%) patients in the bed rest group and 8 (7.7%) in the early mobilization group (p = 0.390). CONCLUSIONS The GET-UP Trial is the first randomized clinical trial to assess the impact of mobilization strategies on medical complications after burr hole craniostomy for cSDH. Early mobilization was associated with a reduction in medical complications without a significant effect on surgical recurrence, compared with a 48-hour bed rest protocol.

INTRODUCTION:Timing for mobilization after chronic subdural hematoma (CSDH) surgery is highly heterogeneous among neurosurgical centers. No high-quality evidence addresses this question.METHODS:Our aim is to recruit a total of 208 patients. Patients are randomized to either an early mobilization group (EMG) where mobilization is required within the first 12 hours post-surgery; or to a bed rest group (BRG) where they remain recumbent for 48 hours after surgery. The primary outcome is medical complications after surgery and until discharge. Secondary outcomes include evaluation of the functional status at 1 year post-op, using Glasgow Outcome Scale Extended (GOS-E) and Short Form 36 Health Survey (SF-36).RESULTS:We present results of the interim analysis at one year post-op referring to the first 104 randomized patients. A total of 52 patients were randomized to each group. Two patients were lost to follow up at one year. No significant baseline demographic differences were observed. A good outcome was considered when patients achieved GOS-E 5 or higher. At one year we observed a tendency towards better outcome in the EMG group with 71% of the patients having a GOS E = 5 against 54% in the BRG group (p = 0.073). Mortality at 1 year demonstrated a tendency to be lower in the EMG group (21% against 30% in the BRG group, p = 0.305). When we analyze our results based on the SF-36 questionnaire, a tendency toward better performance in the EMG is apparent, especially in the physical performance (p = 0.048), mental health (p = 0.037), vitality (p = 0.043) and general health (p = 0.002) subdivisions.CONCLUSION:GET-UP Trial is performing in accordance with the established protocol. This interim analysis’ results validate the methodology and do not pose security concerns even after 1 year follow-up. Active recruitment is ongoing.