Hyperbaric Oxygen BrainInjury Treatment (HOBIT) Trial-SDMC

高压氧脑损伤治疗（HOBIT）试验-SDMC

• 批准号: 9973235
• 负责人: Renee Hebert Martin
• 金额: $ 35.84万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9973235
• 关键词: Applications Grants; Brain; Brain Injuries; Case Report Form; Cell Death; Clinical; Clinical Trials; Clinical Trials Data Monitoring Committees; Clinical effectiveness; Collection; Common Data Element; Companions; Data; Data Analyses; Data Set; Databases; Development; Dose; Economics; Eligibility Determination; Failure; Frequencies; Goals; Health Sciences; Human; Hyperbaric Oxygen; Hyperoxia; Injury; Institutes; Ischemia; Manuscripts; Medical; Michigan; Minnesota; Monitor; Multi-site clinical study; Multicenter Trials; Multiple Trauma; National Institute of Neurological Disorders and Stroke; Neurological emergencies; Neurological outcome; Online Systems; Outcome; Oxygen; Patients; Periodicity; Physiological; Probability; Procedures; Protocols documentation; Public Health; Randomized; Reporting; Research Design; Role; Safety; Schedule; Signal Transduction; Slide; Societies; South Carolina; Specific qualifier value; Statistical Data Interpretation; System; Traumatic Brain Injury; Universities; Work; base; clinical application; clinical investigation; clinical research site; confirmatory trial; data dissemination; data management; data quality; design; efficacy study; efficacy trial; electronic data; experience; improved outcome; innovation; mortality; organizational structure; oxygen toxicity; pre-clinical; preclinical trial; pressure; prospective; response; standard of care; treatment trial; trial design

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).

创伤性脑损伤（TBI）是一种破坏性的疾病， 高死亡率和不良后果的问题。临床前和临床 研究强烈表明，HBO 2在减少脑损伤方面具有生理活性， 改善严重TBI的预后。然而，在进行明确的疗效研究之前， 需要关于优化HBO 2治疗范例的信息， HBO 2治疗的压力和频率以及NBH是否增强临床效果 HBO 2治疗的效果。基于这一令人鼓舞的证据， 项目将是一项随机、前瞻性、多中心、适应性剂量探索临床试验 研究HBO 2治疗严重TBI患者的应用。主要目标将 确定最有效的高氧剂量方案而不产生氧毒性 和临床并发症。基于滑动二分GOS，本研究旨在选择 治疗参数（压力和干预NBH）的组合最有可能 在6个月时表现出改善。其次，审判还旨在确定是否 有> 50%的可能性高氧治疗表明改善了 在随后的确证性试验中，与对照组相比，神经系统结局良好;并告知 决定继续进行并优化随后的验证性试验。试验将 在神经紧急情况治疗试验网络中进行。这一项目的 作为临床协调中心的两个捆绑拨款申请提交（在 明尼苏达大学和密歇根大学）和统计和数据 管理中心（位于南卡罗来纳州医科大学）。