Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial - SDMC SDC Supplement

项目摘要/摘要 创伤性脑损伤(TBI)是一种毁灭性的疾病，它继续对患者产生巨大的影响。 对患有这种疾病的人来说，这是一个死亡率高、预后差的问题。临床前和临床 研究有力地表明，高压氧在生理上具有减少脑损伤和 改善重型颅脑损伤的预后。然而，在明确的疗效研究之前，重要的是 需要关于优化在以下方面建立的HBO2治疗范例的信息 高压氧治疗的压力和频率以及NBH是否改善临床 高压氧治疗的有效性。基于这一有希望的证据，拟议的 该项目将是一项随机、前瞻性、多中心、适应性剂量发现临床试验 重型颅脑损伤患者高压氧治疗效果观察主要目标将是 确定在不产生氧毒性的情况下最有效的高氧剂量方案 和临床并发症。基于滑动二分法的GOS，本研究旨在选择 治疗参数组合(压力和介入性NBH)最有可能 在6个月后表现出改善。其次，审判还旨在确定 有50%的可能性高氧治疗显示出改善的比率。 在随后的验证性试验中，良好的神经学结果与对照比较； 关于继续进行和优化随后的验证性试验的决定。审判将是 在神经紧急情况治疗试验网络中进行。这个项目正在进行中 作为临床协调中心的两份捆绑拨款申请提交(在 明尼苏达大学和密歇根大学)以及统计和数据 管理中心(南卡罗来纳医科大学)。

PROJECT ABSTRACT / SUMMARY Traumatic brain injury (TBI) is a devastating condition which continues to exert an overarching problem of high mortality and poor outcomes on those with this condition. Preclinical and clinical investigations strongly indicate that HBO2 is physiologically active in reducing brain injury and improving outcomes in severe TBI. However, prior to a definitive efficacy study, important information is required regarding optimizing the HBO2 treatment paradigm instituted in terms of pressure and frequency of HBO2 treatments and whether NBH enhances the clinical effectiveness of the HBO2 treatment. Based upon this promising evidence, the proposed project will be a randomized, prospective, multicenter, adaptive dose-finding clinical trial investigating the use of HBO2 treatment for patients with severe TBI. The primary objective will be to determine the most effective hyperoxia dose schedule without producing oxygen toxicity and clinical complications. Based on the sliding dichotomized GOS, the study aims to select the combination of treatment parameters (pressure and intervening NBH) that is most likely to demonstrate improvement at 6 months. Secondly, the trial also aims to determine whether there is a > 50% probability of hyperoxia treatment demonstrating improvement in the rate of good neurological outcome versus control in a subsequent confirmatory trial; and to inform decisions on proceeding to, and optimizing a subsequent confirmatory trial. The trial will be conducted in the Neurological Emergencies Treatment Trials network. This project is being submitted as two bundled grant applications for the Clinical Coordinating Center (at the University of Minnesota and the University of Michigan) and the Statistical and Data Management Center (at the Medical University of South Carolina).