Henaux Pierre-Louis, Le Reste Pierre-Jean, Laviolle Bruno, Morandi Xavier
Department of Neurosurgery, Rennes University Hospital, 2, rue Henri Le Guilloux, 35033, Rennes, Cedex 9, France.
Rennes 1 University, Faculty of Medicine, 2 Avenue du Professeur Léon Bernard, 35043, Rennes, Cedex 4, France.
Trials. 2017 Jun 5;18(1):252. doi: 10.1186/s13063-017-1990-8.
Chronic subdural hematoma (CSDH) is a common neurological pathology, especially in older patients. The actual "gold standard" of treatment is surgical evacuation, with various techniques used across neurosurgical teams. Over the years, there has been growing evidence that inflammatory processes play a major role in the pathogenesis of CSDH. In that context, the use of corticosteroids has been proposed alone or as an adjuvant treatment to surgery. However, this practice remains very empirical and there is a need for high-quality-of-evidence studies to clarify the role of corticosteroids in the management of CSDH.
METHODS/DESIGN: We propose a double-blind, randomized controlled trial comparing methylprednisolone versus placebo in the treatment of CSDH without clinical and/or radiological signs of severity. The treatment will be administered daily for a duration of 3 weeks, at a dose of 1 mg/kg. The primary endpoint will be the delay of occurrence of surgical treatment at 1 month following the introduction of the treatment. Secondary endpoints will include the rate of recourse to surgery, survival rate, quality of life and functional assessments, occurrence of systemic secondary effects and radiological assessment of the response to treatment. This multimodal assessment will be done at 1, 3 and 6 months. Two hundred and two patients (101 per arm) are expected to be included considering our primary hypotheses.
This trial started in June 2016; its results may open interesting alternatives to surgery in the management of patients harboring a CSDH, and may provide insights into the natural history of this common pathology.
ClinicalTrials.gov, ID: NCT02650609 . Registered on 4 January 2016. Graphical output of the OBF boundaries.
慢性硬膜下血肿（CSDH）是一种常见的神经病理学疾病，在老年患者中尤为常见。治疗的实际“金标准”是手术清除血肿，神经外科团队采用了各种技术。多年来，越来越多的证据表明炎症过程在CSDH的发病机制中起主要作用。在这种情况下，有人提出单独使用皮质类固醇或作为手术的辅助治疗。然而，这种做法仍然非常经验性，需要高质量的证据研究来阐明皮质类固醇在CSDH管理中的作用。
方法/设计：我们提出一项双盲、随机对照试验，比较甲基强的松龙与安慰剂在治疗无临床和/或放射学严重体征的CSDH中的效果。治疗将持续3周，每天给药，剂量为1mg/kg。主要终点将是治疗开始后1个月进行手术治疗的延迟时间。次要终点将包括手术求助率、生存率、生活质量和功能评估、全身继发效应的发生情况以及治疗反应的放射学评估。这种多模式评估将在1、3和6个月时进行。考虑到我们的主要假设，预计将纳入202名患者（每组101名）。
该试验于2016年6月开始；其结果可能为CSDH患者的管理提供有趣的手术替代方案，并可能为这种常见疾病的自然史提供见解。
ClinicalTrials.gov，ID：NCT02650609。于2016年1月4日注册。OBF边界的图形输出。
