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Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study.

ABSTRACT: BACKGROUND:Low-dose acetylsalicylic acid (ASA) in patients with chronic subdural hematoma (cSDH) represents a significant neurosurgical challenge. While continuation of ASA during the perioperative phase might increase recurrence and bleeding rates, discontinuation increases the risk of thromboembolic events. The aim of this study is to compare the postoperative recurrence and cardiovascular complication rates of patients undergoing burr-hole trepanation for cSDH with and without discontinuation of ASA. METHODS:In this prospective randomized, placebo-controlled, double-blinded study we include all patients undergoing burr-hole drainage of cSDH who are under ASA treatment. The patients are randomized into two groups, one receiving ASA and the other placebo perioperatively. The study primarily seeks to compare the rate of recurrent events under ASA to that under placebo treatment. Secondary objectives are thromboembolic event rate, perioperative blood loss, postoperative anemia, intra- and postoperative blood transfusion rate, and clinical outcome. DISCUSSION:To date, there is no evidence-based consensus on how to manage patients undergoing burr-hole drainage for cSDH who are under ASA treatment. Therefore, the decision to maintain or interrupt ASA treatment is based mostly on the surgeons' preference. A randomized placebo-controlled study for this frequent question is urgently needed in order to provide class I evidence for the best possible treatment of this large group of patients. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03120182 . Initial Release: 19.04.2017. STUDY PROTOCOL:V2_23.02.2017.

SUBMITTER: Kamenova M

PROVIDER: S-EPMC6341728 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study.

Kamenova Maria M Mueller Christian C Coslovsky Michael M Guzman Raphael R Mariani Luigi L Soleman Jehuda J

Trials 20190121 1

<h4>Background</h4>Low-dose acetylsalicylic acid (ASA) in patients with chronic subdural hematoma (cSDH) represents a significant neurosurgical challenge. While continuation of ASA during the perioperative phase might increase recurrence and bleeding rates, discontinuation increases the risk of thromboembolic events. The aim of this study is to compare the postoperative recurrence and cardiovascular complication rates of patients undergoing burr-hole trepanation for cSDH with and without discont ...[more]

PMID: 30665464

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Project description:Objective:Chronic subdural hematoma (CSDH) is a common disease. Atorvastatin calcium can increase CSDH absorption. However, whether atorvastatin can increase hematoma absorption and reduce recurrence at high altitudes is not clear. Methods:After burr-hole drainage, CSDH patients were divided into an atorvastatin group and a control group. Follow-up computed tomography (CT) was performed on day 1, months 1, 2, and 3 after surgery. Then, the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, and Markwalder grading scale score (MGSS) were calculated, and related risk factors were analyzed. Results:The non-recurrent and recurrent patients in the control group differed significantly in terms of the hemoglobin concentration (HB) [176.24 ± 16.43 vs. 194.25 ± 12.34 (g/L), p < 0.01], CT value [41.92 ± 10.76 vs. 34.12 ± 8.78 (Hu), p < 0.01], and low-density time [3.88 ± 1.04 vs. 5.50 ± 0.87 (d), p < 0.01]. The non-recurrent and recurrent patients in the atorvastatin group differed significantly in terms of the HB [172.66 ± 16.41 vs. 190.45 ± 10.23 (g/L), p < 0.01], CT value [38.91 ± 7.16 vs. 29.50 ± 8.61 (Hu), p < 0.01], and mixed [2 vs. 4 (n), p < 0.05] and low-density time [4.09 ± 0.75 vs. 5.45 ± 1.12 (d), p < 0.01]. The logistic regression analysis showed that HB [odds ratio, 1.14; 95% confidence interval (CI), 1.04-1.25 in the control group, odds ratio, 1.13; 95% CI, 1.03-1.23 in the atorvastatin group] and low-density time (odds ratio, 3.53; 95% CI, 1.42-8.74 in the control group, odds ratio, 2.53; 95% CI, 1.10-5.80 in the atorvastatin group) were possible risk factors for the two groups. The receiver operating characteristic curves showed that the area under the receiver operating characteristic curve values for the HB, CT value (Hu), and low-density time were 0.812, 0.702, and 0.755 for all subjects; 0.812, 0.719, and 0.790 for the control group; and 0.807, 0.682, and 0.756 for the atorvastatin group, respectively. The postoperative follow-up results showed that there was no significant difference in the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, or MGSS between the two groups. Conclusion:The effect of atorvastatin was not significant after the operation. The risk factors for CSDH recurrence were the HB and low-density time. The HB was the most specific and sensitive predictor of CSDH recurrence.

Project description:BackgroundThe aesthetic outcome after burr hole trepanation for the evacuation of chronic subdural hematomas (cSDH) is often unsatisfactory, as the bony skull defects may cause visible skin depressions. The purpose of this study was to evaluate the efficacy of burr hole cover placement to improve the aesthetic outcome.MethodsWe reviewed consecutive patients treated by burr hole trepanation for cSDH with or without placement of burr hole covers by a single surgeon between October 2016 and May 2018. The clinical data, including complications, were derived from the institution's prospective patient registry. The primary endpoint was the aesthetic outcome, as perceived by patients on the aesthetic numeric analog (ANA) scale, assessed by means of a standardized telephone interview. Secondary endpoints were skin depression rates and wound pain, as well as complications.ResultsFrom n = 33, outcome evaluation was possible in n = 28 patients (n = 24 male; mean age of 70.4 ± 16.1 years) with uni- (n = 20) or bilateral cSDH (n = 8). A total of 14 burr hole covers were placed in 11 patients and compared to 50 burr holes that were not covered. Patient satisfaction with the aesthetic outcome was significantly better for covered burr holes (mean ANA 9.3 ± 0.74 vs. 7.9 ± 1.0; p < 0.001). Skin depressions occurred over 7% (n = 1/14) of covered and over 92% (n = 46/50) of uncovered burr holes (p < 0.001). There was no difference in wound pain (p = 0.903) between covered and uncovered sites. No surgical site infection, cSDH recurrence, or material failure was encountered in patients who had received a burr hole plate.ConclusionsIn this retrospective series, placement of burr hole covers was associated with improved aesthetic outcome, likely due to reduction of skin depressions. A randomized controlled trial is developed to investigate whether adding burr hole covers results in superior aesthetic outcomes, without increasing the risk for complications.

Project description:BackgroundBurr hole evacuation is a well-established treatment for symptomatic cases with chronic subdural hematoma (cSDH). Routinely postoperative catheter is left in the subdural space to drain the residual blood. Drainage obstruction is commonly seen, and it can be related to suboptimal treatment.MethodsTwo groups of patients submitted to cSDH surgery were evaluated in a retrospective non-randomized trial, one group that had conventional subdural drainage (CD group, n = 20) and another group that used an anti-thrombotic catheter (AT group, n = 14). We compared the obstruction rate, amount of drainage and complications. Statistical analyses were done using SPSS (v.28.0).ResultsFor AT and CD groups respectively (median ± IQR), the age was 68.23 ± 26.0 and 70.94 ± 21.5 (p > 0.05); preoperative hematoma width was 18.3 ± 11.0 mm and 20.7 ± 11.7 mm and midline shift was 13.0 ± 9.2 and 5.2 ± 8.0 mm (p = 0.49). Postoperative hematoma width was 12.7 ± 9.2 mm and 10.8 ± 9.0 mm (p < 0.001 intra-groups compared to preoperative) and MLS was 5.2 ± 8.0 mm and 1.5 ± 4.3 mm (p < 0.05 intra-groups). There were no complications related to the procedure including infection, bleed worsening and edema. No proximal obstruction was observed on the AT, but 8/20 (40%) presented proximal obstruction on the CD group (p = 0.006). Daily drainage rates and length of drainage were higher in AT compared to CD: 4.0 ± 1.25 days vs. 3.0 ± 1.0 days (p < 0.001) and 69.86 ± 106.54 vs. 35.00 ± 59.67 mL/day (p = 0.074). Symptomatic recurrence demanding surgery occurred in two patients of CD group (10%) and none in AT group (p = 0.230), after adjusting for MMA embolization, there was still no difference between groups (p = 0.121).ConclusionThe anti-thrombotic catheter for cSDH drainage presented significant less proximal obstruction than the conventional one and higher daily drainage rates. Both methods demonstrated to safe and effective for draining cSDH.

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Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study.

Publications

Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study.

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