Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial - CCC

高压氧脑损伤治疗 (HOBIT) 试验 - CCC

• 批准号: 9979966
• 负责人: WILLIAM G BARSAN
• 金额: $ 138.13万
• 依托单位: HENNEPIN HEALTHCARE RESEARCH INSTITUTE
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979966
• 关键词: Admission activity; Area Under Curve; Atmosphere; Brain; Brain Injuries; Cell Death; Cell Respiration; Cerebrum; Clinical; Clinical Data; Clinical Trials; Clinical effectiveness; Common Data Element; Companions; Conduct Clinical Trials; Control Groups; Data; Dose; Economics; Enrollment; Ensure; Failure; Frequencies; Funding; Futility; Future; Glasgow Outcome Scale; Human; Hyperbaric Oxygen; Hyperbaric Oxygenation; Hyperoxia; Hypoxia; Injury; Institutes; Intracranial Hypertension; Intracranial Pressure; Ischemia; Lung; Methodology; Monitor; Multiple Trauma; National Institute of Neurological Disorders and Stroke; Neurological emergencies; Neurological outcome; Outcome; Oxygen; Partial Pressure; Patients; Phase; Physiological; Probability; Production; Randomized; Reporting; Safety; Sample Size; Schedule; Serious Adverse Event; Signal Transduction; Site; Slide; Societies; Statistical Data Interpretation; Therapeutic; Tissues; Toxic effect; Traumatic Brain Injury; Treatment Protocols; United States National Institutes of Health; Work; active method; arm; base; brain cell; brain tissue; clinical center; clinical investigation; confirmatory trial; data management; data quality; design; effective therapy; efficacy study; efficacy trial; experimental arm; improved; improved outcome; innovation; lung injury; mortality; oxygen toxicity; phase III trial; pre-clinical; pressure; primary outcome; response; standard care; standard of care; treatment arm; treatment effect; treatment trial; ventilator-associated pneumonia

There continues to be an overarching problem of high mortality and poor outcome for victims of severe traumatic brain injury (TBI). Preclinical and clinical investigations indicate that hyperbaric oxygen (HBO2) has a positive impact on reducing brain injury and improving outcomes in severe TBI. By markedly increasing oxygen (O2) delivery to the traumatized brain, HBO2 can reverse the lack of O2 that precipitates cellular energy failure and subsequent brain cell death. In past clinical investigations, HBO2 in comparison to standard care has significantly improved energy production in the brain and improved clinical outcome. However, prior to a formal phase III definitive efficacy study, important information is required regarding optimizing the HBO2 treatment schedule to be instituted in terms of pressure and frequency and other parameters. The lungs in severe TBI patients have frequently been compromised by direct lung injury and/or acquired ventilator pneumonia and are susceptible to O2 toxicity. It is essential to determine the most effective HBO2 dose schedule without producing O2 toxicity and clinical complications. This proposed adaptive clinical trial is designed to answer these questions and to provide important data to plan a definitive phase III efficacy trial. Primary aims of this trial are to select, in patients with severe TBI, the combination of HBO2 treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Also the trial will determine, in patients with severe TBI, whether there is a > 50% probability of HBO2 treatment demonstrating improvement in the outcome of severe TBI in a subsequent confirmatory phase III trial. This trial is supported and sponsored by the Neurological Emergency Treatment Trial (NETT) Network which is funded by the National Institutes of Neurologic Disease and Stroke to conduct clinical trials such as the one described. The NETT helps ensure a well-planned and well-conducted clinical trial.

仍然存在一个突出的问题，即高死亡率和不良结局。 严重创伤性脑损伤(TBI)受害者。临床前和临床研究表明 高压氧(HBO2)对减轻脑损伤、改善病情有积极作用 重型颅脑损伤的转归。通过显著增加氧气(O2)向受伤大脑的输送， 高压氧可以逆转导致细胞能量衰竭和随后的脑功能衰竭的氧气缺乏 细胞死亡。在过去的临床研究中，与标准护理相比，HBO2显著 改善大脑中的能量产生，改善临床结果。然而，在一个 正式的第三阶段最终疗效研究，需要有关优化的重要信息 高压氧治疗计划将在压力和频率等方面制定 参数。重型颅脑损伤患者的肺经常受到直接肺的损害。 损伤和/或获得性呼吸机肺炎，并容易受到氧气中毒的影响。这是至关重要的 确定在不产生氧气毒性的情况下最有效的HBO2剂量方案 并发症。这项拟议的适应性临床试验旨在回答这些问题和 为计划最终的III期疗效试验提供重要数据。 这项试验的主要目的是在重型颅脑损伤患者中选择联合 最有可能显示改善预后的HBO2治疗参数 在随后的III期试验中，重型颅脑损伤患者。此外，试验还将确定，在患有 重型颅脑损伤，是否有50%的概率高压氧治疗证明 在随后的验证性III期试验中，重型颅脑损伤的结果有所改善。 这项试验是由神经急救试验支持和赞助的 (NETT)网络，由美国国立神经疾病和中风研究所资助 进行如上所述的临床试验。NETT有助于确保一个计划周密的 进行了良好的临床试验。