Optimal drainage time after evacuation of chronic subdural haematoma (DRAIN TIME 2): a multicentre, randomised, multiarm and multistage non-inferiority trial in Denmark.

BACKGROUND: Postoperative drainage after surgical evacuation of chronic subdural haematoma reduces the risk of recurrence, but the optimum drainage time is uncertain. We aimed to investigate the shortest possible drainage time without increasing the haematoma recurrence rate. METHODS: We conducted a randomised, multi-arm and multistage non-inferiority trial at four neurosurgical centres in Denmark. We enrolled adult patients (aged ≥18 years) with symptomatic chronic subdural haematoma. All patients were treated according to the national standard practice with a burr hole above the maximum width of the haematoma. Patients were randomly assigned in a 1:1:1 ratio via a centralised web server to receive 6 h, 12 h, or 24 h of postoperative passive subdural drainage. Randomisation was done by an independent on-call neurosurgeon and was masked until 6 h after surgery. The primary outcome was symptomatic haematoma recurrence at 3 months after surgery; the rate of recurrence was assessed in a regression model for non-inferiority testing, with no missing data. Personnel assessing the primary outcome were masked to group allocation. Non-inferiority was assessed with a prespecified margin of 7%, in a modified intention-to-treat population-defined as patients with randomly assigned treatment excluding those withdrawing from study participation after randomisation, or experiencing acute rebleedings or accidental drain removal. This trial is registered with ISRCTN (number 15186366); the trial was stopped after the first interim analysis on the advice of an independent safety advisory committee. FINDINGS: Between March 1, 2021, and June 30, 2022, 347 patients were enrolled and 331 were followed up to 3 months, 105 were assigned to 6 h of drainage, 111 to 12 h of drainage, and 115 to 24 h of drainage. At admission, 83 (25%) participants were women and 248 (75%) were men, mean age was 75·7 years (SD 10·5), median modified Rankin Scale score was 4 (IQR 3-5), and median Glasgow Coma Scale score was 15 (IQR 14-15). At 3 months after surgery, haematoma recurrence was reported in 28 (27%) of 105 patients who were assigned to 6 h drainage (predicted haematoma recurrence rate 27·0%, 95% CI 18·5 to 35·4), 22 (20%) of 111 assigned to 12 h drainage (19·5%, 12·0 to 27·0), and 12 (10%) of 115 assigned to 24 h drainage (10·4%, 4·8 to 16·0). The risk of haematoma recurrence was increased by 16·5 percentage points (95% CI 6·5 to 26·6) in patients drained for 6 h compared with 24 h, and by 9·1 percentage points (-0·4 to 18·5) in patients drained for 12 h compared with 24 h. Therefore, non-inferiority of 6 h and 12 h of drainage to 24 h of drainage was not established. 20 patients had died by 3 months, seven in the 6 h group, eight in the 12 h group, and five in the 24 h group. The most frequent known causes of death were haematoma recurrence (three in 12 h group), comorbidity (three in 12 h group), and pneumonia (one each in 6 h and 12 h groups, two in 24 h group). The most frequent complication was postoperative infection, reported in 20 (20%) patients in the 6 h group, 25 (23%) in the 12 h group, and 19 (17%) in the 24 h group. The most common infection source was the urinary tract. INTERPRETATION: Patients surgically treated for symptomatic chronic subdural haematoma and postoperatively drained for 6 h or 12 h had higher rates of haematoma recurrence than did patients drained for 24 h. The findings from this non-inferiority trial provide evidence to support 24 h of postoperative drainage as the standard drain time when a fixed drain time approach is used. To provide solid evidence of generalisability of the results to countries other than Denmark, a multinational randomised controlled trial will be needed. FUNDING: None.

Early spontaneous cessation of subdural drainage after burr hole evacuation of chronic subdural hematoma and risk of recurrence.

OBJECTIVE: Subdural drainage reduces recurrence after evacuation of chronic subdural hematoma (CSDH). In the present study, the authors investigated the dynamics of drain production and potentially contributing factors for recurrence. METHOD: Patients treated with a single burr hole evacuation of CSDH between April 2019 and July 2020 were included. Patients were also participants in a randomized controlled trial. All patients included, had a passive subdural drain for exactly 24 hours. Drain production, Glasgow Coma Scale score, and degree of mobilization was recorded every hour for 24 hours. A CSDH successfully drained for 24 hours is referred to as a "case". Patients were followed for 90 days. Primary outcome was symptomatic recurrent CSDH requiring surgery. RESULTS: A total of 118 cases from 99 patients were included in the study. Of the 118 cases, 34 (29%) had spontaneous drain cessation within the first 0-8 hours after surgery (Group A), 32 (27%) within 9-16 hours (Group B), and 52 (44%) within 17-24 hours (Group C). Hours of production (P < 0.000) and total drain volume (P = 0.001) were significantly different between groups. The recurrence rate was 26.5% in group A, 15.6% in group B, and 9.6% in group C (P = 0.037). Multivariable logistic regression analysis show that cases in group C (OR: 0.13, P = 0.005) are significantly less likely to recur compared to group A. Only in 8 of the 118 cases (6.8%), the drain started draining again after an interval of three consecutive hours. CONCLUSIONS: Early spontaneous cessation of subdural drain production seems to be associated with increased risk of recurrent hematoma. Patients with early cessation of drainage did not benefit from further drain time. Observations of the present study indicate personalized drainage discontinuation strategy as a potentially alternative to a specific discontinuation time for all CSDH patients.

National randomized clinical trial on subdural drainage time after chronic subdural hematoma evacuation.

OBJECTIVE: Placement of a subdural drain reduces recurrence and death after evacuation of chronic subdural hematoma (CSDH), but little is known about optimal drainage duration. In the present national trial, the authors investigated the effect of drainage duration on recurrence and death. METHODS: In a randomized controlled trial involving all neurosurgical departments in Denmark, patients treated with single burr hole evacuation of CSDH were randomly assigned to 24 hours or 48 hours of postoperative passive subdural drainage. Follow-up duration was 90 days, and the primary study outcome was recurrent hematoma requiring reoperation. Secondary outcome was death. In addition, complications and length of hospital stay were recorded and analyzed. RESULTS: Of the 420 included patients, 212 were assigned 24-hour drainage and 208 were assigned 48-hour drainage. The recurrence rate was 14% in the 24-hour group and 13% in the 48-hour group. Four patients died in the 24-hour group, and 8 patients died in the 48-hour group; this difference was not statistically significant. The ORs (95% CIs) for recurrence and mortality (48 hours vs 24 hours) were 0.94 (0.53-1.66) and 2.07 (0.64-7.85), respectively, in the intention-to-treat analysis. The ORs (95% CIs) for recurrence and mortality per 1-hour increase in drainage time were 1.0005 (0.9770-1.0244) and 1.0046 (0.9564-1.0554), respectively, in the as-treated sensitivity analysis that used the observed drainage times instead of the preassigned treatment groups. The rates of surgical and drain-related complications, postoperative infections, and thromboembolic events were not different between groups. The mean ± SD postoperative length of hospital stay was 7.4 ± 4.3 days for patients who received 24-hour drainage versus 8.4 ± 4.9 days for those who received 48-hour drainage (p = 0.14). The mean ± SD postoperative length of stay in the neurosurgical department was significantly shorter for the 24-hour group (2 ± 0.9 days vs 2.8 ± 1.6 days, p < 0.001). CONCLUSIONS: No significant differences in the rates of recurrent hematoma or death during 90-day follow-up were identified between the two groups that randomly received either 24- or 48-hour passive subdural drainage after burr hole evacuation of CSDH.