BackgroundChronic subdural hematoma (CSDH) is a common disease that is more prevalent in older people. Surgical intervention is a safe treatment of choice. However, the recurrence rate is relatively high and the outcome is not always satisfactory among surgically treated patients. It is believed that aberrant angiogenesis and intracapsular inflammation contribute to the development of CSDH. Atorvastatin is reported to promote angiogenesis and suppress inflammation. We have recently shown that atorvastatin is effective to non-surgically reduce and eliminate CSDH with minimal side effects. Here, we report a clinical research trial protocol that is designed to evaluate the therapeutic effects of atorvastatin on CSDH.Methods/DesignWe have designed a multi-center, randomized, placebo-controlled, double blind clinical trial for evaluating the efficacy of oral atorvastatin in reducing CSDH. We have so far recruited 96 patients with CT-confirmed or MRI-confirmed CSDHs from 16 medical centers in China. These patients were originally recruited for the Oriental Neurosurgical Evidence-based Study Team (ONET) study. After informed consent is provided, patients are randomized to receive either atorvastatin (oral 20 mg/night for 8 weeks) or placebo (dextrin for 8 weeks); and followed for 16 weeks after the treatment. The primary outcome is the change in hematoma volume at the end of 8-week treatment. Secondary outcomes include: changes in 1) the hematoma volume at the 4th, 12th, and 24th weeks; 2) Markwalder’s Grading Scale and Glasgow Coma Scale (MGS-GCS); 3) Glasgow Outcome Score (GOS) and 4) Activities of Daily Life – the Barthel Index scale (ADL-BI). Safety will be assessed during the study by monitoring adverse events, laboratory tests, electrocardiography (ECG), measurements of vital signs (temperature, pulse, and blood pressure) and body weight.DiscussionResults of this trial will provide critical information regarding whether atorvastatin is an effective and safe alternative to surgical treatment of CSDH.Trial registrationClinicalTrials.gov Identifier – NCT02024373The date of trial registration: 7 August 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1045-y) contains supplementary material, which is available to authorized users.

Background Chronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve outcomes, presumably by reducing local inflammation and promoting vascular repair. We wish to extend this evidence in a study that aims to determine the efficacy and safety of atorvastatin combined with low-dose dexamethasone in patients with CSDH. Methods The second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-centre, randomized, placebo-controlled, double-blind trial which aims to enrol 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition and reduction in haematoma volumes at 14, 28 and 90 days. Discussion This multi-centre clinical trial aims to provide high-quality evidence on the efficacy and safety of the combined treatment of atorvastatin and low-dose dexamethasone to reduce inflammation and enhance angiogenesis in CSDH. Trial registration ChiCTR, ChiCTR1900021659. Registered on 3 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=36157.

Background: The effects of intravenous and inhalation anesthesia on intraoperative and postoperative pulmonary inflammatory responses have been reported in many studies. The differences in clinical postoperative pulmonary complications (PPCs) have been also studied in cardiac and lung resection surgery. However, there are few relevant reports and the findings remain controversial. Clinical evidence for the effects of these two anesthetics on PPCs in other types of surgery is still missing. The main goal of the current study was to assess the impact of sevoflurane and propofol on the incidence of PPCs in patients undergoing oral and maxillofacial surgery. Methods: In this double-blind, randomized, controlled trial, we randomly assigned 220 adults at intermediate-to-high risk of pulmonary complications after oral and maxillofacial cancer surgery with radial forearm or fibular flap reconstruction to either propofol or sevoflurane as a general anesthetic. The occurrence of pulmonary complications according to the Clavien-Dindo score was defined as the primary (within 7 days after surgery) outcome. Results: The two intervention groups had similar characteristics at baseline. The PPCs incidence during 7 days after surgery was 32.4% and 18.2% in the propofol and sevoflurane groups, respectively (adjusted relative risk, 0.44; 95% confidence interval [CI], 0.22 to 0.91; P = 0.027). The corresponding incidence of PPCs in patients who underwent tracheotomy at the end of surgery in the two groups was 44.8% and 24.5% (adjusted relative risk, 0.39; 95% CI, 0.17 to 0.91; P = 0.030). In addition, the Clavien-Dindo classification showed significant differences between groups in minor complications (grade I and II) but not in major complications (grade III to V). Intergroup difference in the time to occurrence of the first PPC after surgery was significant (P = 0.021). There was no difference in postoperative hospital stay between the two groups. Conclusions: Compared with intravenous anesthesia, the administration of sevoflurane reduces the incidence of minor PPCs (grade I to II) in moderate- and high-risk patients who have undergone tracheotomy after oral and maxillofacial cancer surgery with radial forearm or fibular flap reconstruction.

Background Chronic subdural haematoma (CSDH) is a common condition in the elderly that often requires neurosurgical management. For small CSDH, evidence has emerged that statins may reduce haematoma volume and improve outcomes, presumably by reducing local inflammation and promoting vascular repair. We wish to extend this evidence in a study that aims to determine the efficacy and safety of atorvastatin combined with low-dose dexamethasone in patients with CSDH. Methods The second ATorvastatin On Chronic subdural Hematoma (ATOCH-II) study is a multi-center, randomized, placebo-controlled, double blind trial which aims to enroll 240 adult patients with a conservative therapeutic indication for CSDH, randomly allocated to standard treatment with atorvastatin 20 mg combined with low-dose dexamethasone (or matching placebos) daily for 28 days, and with 152 days of follow-up. The primary outcome is a composite good outcome defined by any reduction from baseline in haematoma volume and survival free of surgery at 28 days. Secondary outcomes include functional outcome on the modified Rankin scale (mRS) and modified Barthel Index at 28 days, surgical transition, and reduction in haematoma volumes at 14, 28 and 90 days. Discussion This multi-centre clinical trial aims to provide high-quality evidence on the efficacy and safety of the combined treatment of atorvastatin and low-dose dexamethasone to reduce inflammation and enhance angiogenesis in CSDH. Trial registration: ChiCTR, ChiCTR1900021659. Registered 3 March 2019, http://www.chictr.org.cn/showproj.aspx?proj=36157