Hyperbaric Oxygen BrainInjury Treatment (HOBIT) Trial-SDMC Supplement FITBIR

高压氧脑损伤治疗 (HOBIT) 试验-SDMC 补充 FITBIR

基本信息

批准号：
10607604
负责人：
Renee Hebert Martin
金额：
$ 9.64万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-01 至 2023-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10607604
关键词：
Applications Grants Brain Brain Injuries Case Report Form Cell Death Clinical Clinical Trials Clinical Trials Data Monitoring Committees Clinical effectiveness Collection Common Data Element Companions Data Data Analyses Data Set Databases Development Dose Economics Eligibility Determination Failure Frequencies Goals Health Sciences Human Hyperbaric Oxygen Hyperoxia Injury Institutes Ischemia Manuscripts Medical Michigan Minnesota Monitor Multi-site clinical study Multicenter Trials Multiple Trauma National Institute of Neurological Disorders and Stroke Neurological emergencies Neurological outcome Online Systems Outcome Oxygen Patients Periodicity Physiological Probability Procedures Protocols documentation Public Health Randomized Reporting Research Design Role Safety Schedule Signal Transduction Slide Societies South Carolina Specific qualifier value Statistical Data Interpretation System Traumatic Brain Injury Universities Work base clinical application clinical investigation clinical research site confirmatory trial data dissemination data management data quality design efficacy study efficacy trial electronic data experience improved outcome innovation mortality organizational structure oxygen toxicity pre-clinical preclinical trial pressure prospective response standard of care treatment trial trial design

项目摘要

PROJECT ABSTRACT / SUMMARY Traumatic brain injury (TBI) is a devastating condition which continues to exert an overarching problem of high mortality and poor outcomes on those with this condition. Preclinical and clinical investigations strongly indicate that HBO2 is physiologically active in reducing brain injury and improving outcomes in severe TBI. However, prior to a definitive efficacy study, important information is required regarding optimizing the HBO2 treatment paradigm instituted in terms of pressure and frequency of HBO2 treatments and whether NBH enhances the clinical effectiveness of the HBO2 treatment. Based upon this promising evidence, the proposed project will be a randomized, prospective, multicenter, adaptive dose-finding clinical trial investigating the use of HBO2 treatment for patients with severe TBI. The primary objective will be to determine the most effective hyperoxia dose schedule without producing oxygen toxicity and clinical complications. Based on the sliding dichotomized GOS, the study aims to select the combination of treatment parameters (pressure and intervening NBH) that is most likely to demonstrate improvement at 6 months. Secondly, the trial also aims to determine whether there is a > 50% probability of hyperoxia treatment demonstrating improvement in the rate of good neurological outcome versus control in a subsequent confirmatory trial; and to inform decisions on proceeding to, and optimizing a subsequent confirmatory trial. The trial will be conducted in the Neurological Emergencies Treatment Trials network. This project is being submitted as two bundled grant applications for the Clinical Coordinating Center (at the University of Minnesota and the University of Michigan) and the Statistical and Data Management Center (at the Medical University of South Carolina).

项目摘要/摘要创伤性脑损伤 (TBI) 是一种毁灭性的疾病，持续对患者造成总体影响患有这种疾病的人面临高死亡率和不良结果的问题。临床前和临床研究强烈表明 HBO2 在减少脑损伤方面具有生理活性改善严重 TBI 的预后。然而，在进行明确的疗效研究之前，重要的是需要关于优化 HBO2 治疗范式的信息 HBO2 治疗的压力和频率以及 NBH 是否增强临床疗效 HBO2 治疗的有效性。基于这一有希望的证据，拟议的项目将是一项随机、前瞻性、多中心、适应性剂量探索临床试验调查 HBO2 治疗严重 TBI 患者的情况。主要目标将确定最有效的高氧剂量方案而不产生氧中毒和临床并发症。基于滑动二分GOS，本研究旨在选择最有可能的治疗参数组合（压力和干预 NBH） 6 个月时表现出改善。其次，审判还旨在确定是否高氧治疗有 > 50% 的可能性显示出改善的发生率在随后的验证性试验中，与对照相比，神经学结果良好；并通知关于继续和优化后续验证性试验的决定。审判将在在神经紧急情况治疗试验网络中进行。该项目正在作为临床协调中心的两份捆绑拨款申请提交（在明尼苏达大学和密歇根大学）以及统计和数据管理中心（位于南卡罗来纳医科大学）。