高压氧脑损伤治疗 (HOBIT) 试验

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

项目类别：

财政年份：

2017

资助国家：

美国

项目状态：

已结题

起止时间：

2017-09-30 至 2023-06-30

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

中文摘要

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英文摘要

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.

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