Determining if Cerebrospinal Fluid Prevents Recurrence of Chronic Subdural Hematoma: A Multi-Center Prospective Randomized Clinical Trial.

Over the decades, the problem of postoperative recurrence of chronic subdural hematoma (CSDH) has not been resolved. The objective of our study was to investigate whether the recurrence rate of CSDH is decreased when artificial cerebrospinal fluid (ACF) is used as irrigation solution for CSDH surgery. The present study was a multi-center, prospective, randomized, open parallel group comparison test of patients enrolled from 10 hospitals in Japan. Eligible patients with CSDH were randomly assigned to undergo burr hole drainage with either normal saline (NS) or ACF irrigation. The primary end-point was postoperative recurrence of ipsilateral CSDH. A total of 402 patients with newly diagnosed CSDH were enrolled during the study period. After applying inclusion and exclusion criteria, and taking into consideration cases lost to follow-up, our final study cohorts consisted of 177 ACF patients and 165 NS patients, representing 85.7% of the initial cohort. The overall recurrence rate was 11.4%, occurring in 39 of the 342 analyzed patients during 90 days of follow-up. Recurrence rates in the ACF and NS groups were 11.9% (21 of 177) and 10.9% (18 of 165), respectively. No significant difference was evident between groups (p = 0.87). In addition, no significant difference in time to recurrence was seen between groups (p = 0.74). No serious adverse effects related to irrigation fluid were seen in either group. Regarding the irrigation fluid for CSDH surgery, no differences in recurrence rate or time to recurrence were seen between the ACF and NS groups. However, ACF offers sufficient safety as irrigation fluid for CSDH.

RCT Entities:   Population Interventions Outcomes