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.

仍然存在一个高死亡率和不良结果的总体问题严重创伤性脑损伤（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有积极影响严重TBI的结果。通过明显增加氧气（O2）向受创伤的大脑递送 HBO2可以扭转缺乏沉淀细胞能量失效和随后大脑的O2 细胞死亡。在过去的临床研究中，与标准护理相比，HBO2显着改善了大脑的能量产生并改善了临床结局。但是，在正式的第三阶段确定性疗效研究，需要有关优化的重要信息 HBO2治疗时间表将以压力和频率以及其他参数。严重TBI患者的肺经常被直接肺部损害损伤和/或获得的呼吸机肺炎，并且容易受到O2毒性的影响。至关重要确定最有效的HBO2剂量时间表，而无需产生O2毒性和临床并发症。拟议的自适应临床试验旨在回答这些问题和提供重要数据以计划确定的III期疗效试验。该试验的主要目的是在严重TBI的患者中选择组合 HBO2治疗参数最有可能证明结果的改善在随后的III期试验中，严重的TBI患者。此外，试验将确定患者严重的TBI，HBO2治疗的可能性> 50％证明在随后的III阶段试验中，严重TBI结果的改善。该试验由神经系统紧急治疗试验支持和赞助（NetT）由国立神经疾病研究所资助的网络进行临床试验，例如所述的试验。净帮助有助于确保精心计划和良好的临床试验。