Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial - CCC

高压氧脑损伤治疗 (HOBIT) 试验 - CCC

基本信息

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
项目类别：
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

项目摘要

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.

死亡率高、预后差的总体问题仍然存在严重创伤性脑损伤 (TBI) 的受害者。临床前和临床研究表明高压氧（HBO2）对减少脑损伤和改善脑损伤具有积极作用严重 TBI 的结果。通过显着增加向受伤大脑输送的氧气 (O2)， HBO2 可以逆转导致细胞能量衰竭和随后大脑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 显着改善大脑的能量产生并改善临床结果。然而，在之前正式的 III 期明确疗效研究，需要有关优化的重要信息根据压力、频率等制定 HBO2 治疗计划参数。严重 TBI 患者的肺部经常受到直接肺损伤的损害损伤和/或获得性呼吸机肺炎，并且容易受到氧气中毒的影响。至关重要的是确定最有效的 HBO2 剂量方案而不产生 O2 毒性和临床并发症。这项拟议的适应性临床试验旨在回答这些问题为规划最终的 III 期疗效试验提供重要数据。该试验的主要目的是在严重 TBI 患者中选择以下药物的组合：最有可能改善结果的 HBO2 治疗参数随后的 III 期试验中的严重 TBI 患者。该试验还将确定，在患者中严重 TBI，HBO2 治疗的可能性是否 > 50% 在随后的验证性 III 期试验中，严重 TBI 的结果有所改善。该试验由神经紧急治疗试验支持和赞助 (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 有助于确保精心策划和进行良好的临床试验。