Background: Chronic 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/Design: We 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. Discussion: Results of this trial will provide critical information regarding whether atorvastatin is an effective and safe alternative to surgical treatment of CSDH.
基金:
National Natural Science Foundation of ChinaNational Natural Science Foundation of China [2011DFG33430, 81100920, 81200907, 81271361, 81271359, 81301629, 81501069, 81502171]; Tianjin Research Program of Application Foundation and Advanced Technology [11JCZDJC18100, 12jcqnjc07200, 12JCQNJC6800]
语种:
外文
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2014]版:
大类|3 区医学
小类|4 区医学:研究与实验
最新[2023]版:
大类|4 区医学
小类|4 区医学:研究与实验
第一作者:
第一作者机构:[1]Tianjin Med Univ, Gen Hosp, Dept Neurosurg, Tianjin 300052, Peoples R China;[2]Minist Educ, Key Lab Posttrauma Neurorepair & Regenerat Cent N, Tianjin 300052, Peoples R China;[3]Tianjin Key Lab Injuries Variat & Regenerat Nervo, Tianjin 300052, Peoples R China;[4]Tianjin Neurol Inst, Tianjin 300052, Peoples R China;[5]Oriental Neurosurg Evidence Based Study Team ONET, Tianjin 300052, Peoples R China;
通讯作者:
通讯机构:[1]Tianjin Med Univ, Gen Hosp, Dept Neurosurg, Tianjin 300052, Peoples R China;[2]Minist Educ, Key Lab Posttrauma Neurorepair & Regenerat Cent N, Tianjin 300052, Peoples R China;[3]Tianjin Key Lab Injuries Variat & Regenerat Nervo, Tianjin 300052, Peoples R China;[4]Tianjin Neurol Inst, Tianjin 300052, Peoples R China;[5]Oriental Neurosurg Evidence Based Study Team ONET, Tianjin 300052, Peoples R China;[27]Tianjin Med Univ, Gen Hosp, Dept Neurosurg, 154 Anshan Rd, Tianjin 300052, Peoples R China
推荐引用方式(GB/T 7714):
Jiang Rongcai,Wang Dong,Poon Wai Sang,et al.Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial[J].TRIALS.2015,16(1):-.doi:10.1186/s13063-015-1045-y.
APA:
Jiang, Rongcai,Wang, Dong,Poon, Wai Sang,Lu, Yi Cheng,Li, Xin Gang...&Zhang, Jian Ning.(2015).Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial.TRIALS,16,(1)
MLA:
Jiang, Rongcai,et al."Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial".TRIALS 16..1(2015):-