权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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：
10449195
负责人：
WILLIAM G BARSAN
金额：
$ 91.63万
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 2024-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10449195
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 Persons 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.

仍然有一个首要问题，即高死亡率和不良结局，严重创伤性脑损伤（TBI）患者。临床前和临床研究表明，高压氧（HBO 2）对减少脑损伤和改善严重TBI的结果。通过显著增加氧气（O2）输送到受创伤的大脑， HBO 2可以逆转导致细胞能量衰竭和随后的脑损伤的O2缺乏细胞死亡在过去的临床研究中，与标准治疗相比，HBO 2具有显著的改善大脑中的能量产生和改善临床结果。然而，在A 正式的III期确定性疗效研究，需要有关优化的重要信息根据压力和频率以及其他方面制定HBO 2治疗计划参数严重TBI患者的肺部经常受到直接肺损伤的影响，损伤和/或获得性呼吸机肺炎，易受O2毒性影响。有必要确定最有效的HBO 2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，提供重要数据，以计划确定的III期疗效试验。本试验的主要目的是在重度TBI患者中选择以下联合治疗：最有可能证明改善以下结局的HBO 2治疗参数：在随后的III期临床试验中，此外，试验将确定，在患者中，严重TBI，是否存在> 50%的HBO 2治疗概率，在随后的确证性III期试验中，严重TBI的结局有所改善。本试验由神经系统紧急治疗试验支持和赞助由美国国立神经疾病和中风研究所资助的网络，进行临床试验，如所描述的。NETT有助于确保计划周密，进行良好的临床试验。