Resuscitation Outcomes Consortium Regional Clinical Center-DFW Center for Resusci

描述（由申请人提供）：复苏结局联盟（ROC）由9个区域临床中心和一个数据和协调中心组成，正在进行多项合作试验，以实现其长期目标，即快速转化有前途的科学和临床进展，以改善院外环境中的复苏结局。ROC已经建立了前所未有的基础设施，在245个EMS机构和近35，000个EMS供应商中成功实现了这一目标（在紧急情况下使用知情同意例外），覆盖了整个北美超过2200万人口，ROC已经证明了其快速推进紧急心脏和创伤护理领域的能力。该提案提出了为ROC提供6年资助的理由，以继续改善这些重要的国家医疗保健问题的结果。联合会的三个具体目标是通过以下方式进一步推动这些领域：1）继续扩大和调查心脏骤停和创伤性损伤Epistry数据库（已经是世界上同类资源中最大的），2）在未来18个月内完成正在进行的心脏骤停和创伤性损伤研究，以及3）实施并完成多个额外的心脏骤停和创伤性损伤临床试验。在更新期内完成的科学上最有效的创伤干预包括：1）立即与延迟静脉输液以减少出血和随后的再灌注损伤，2）静脉内雌激素以减少再灌注损伤的程度，3）静脉内戊茶碱以减少再灌注后炎症介质和反应性氧化剂的释放。科学上最有效的心脏骤停干预包括：1）连续按压与标准CPR相比，以提高生存率，2）在恢复循环后立即实施治疗性低温，以减少再灌注损伤并提高生存率和质量结局。申请中详细说明了实现这些建议的研究设计、原理和技术。通过这次为期6年的续约，ROC将利用其无与伦比的基础设施，显著降低心脏骤停和创伤性损伤的发病率和死亡率。最后，多伦多工厂还计划通过申请临床研究开发技能核心来扩大培训机会。 心血管疾病是美国人死亡的主要原因。创伤是北美儿童、青少年和年轻人（1-44岁）死亡的主要原因。通过继续复苏结局联盟倡议，生存率和生活质量的改善将对这些主要的国家医疗保健问题产生重大影响。(End摘要） 简历：在这些优秀/非常好的应用中，复苏结局联盟（ROC）建议1）继续扩展和调查心脏骤停和创伤性损伤Epistry数据库，2）完成正在进行的心脏骤停和创伤性损伤研究，3）实施和完成多项额外的心脏骤停和创伤性损伤临床试验。该联盟的优势是：主要研究者的专业知识，ROC作为一个整体在改善院外心肺骤停（OOH-CA）和危及生命的创伤性损伤（LTI）方面的重要性，以及各中心的协调/合作。有几个缺点降低了热情。在审查期间详细讨论的一些主要问题是：1）审查者认为创伤在联盟中的代表性不足，需要更多地接触创伤社区; 2）有人担心，当通过电话和/或材料对患者进行随访时，需要使用英语和西班牙语以外的语言进行随访，因为美国和加拿大使用其他语言; 3）对以下声明的担忧：在院前设置中，提供者打电话来确定他们将向患者提供哪些研究或研究材料-这被认为是无效或无效的; 4）对研究中缺失的人口统计数据存在重大担忧-特别是来自加拿大的研究。 审查者不明白为什么提供者至少不能对患者的种族和性别做出合理的猜测，以及为什么不能制定更好的跟踪患者的方法。此外，还有人评论说，加拿大的中心只注重城市中心，而不注重农村地区，而且缺乏对加拿大公众的宣传。 该联盟将对美国和加拿大的生存和生活质量产生重大影响。

Description (provided by applicant): The Resuscitation Outcomes Consortium (ROC), consisting of 9 Regional Clinical Centers and a Data and Coordinating Center, is conducting multiple collaborative trials to achieve its long-term objective of rapid translation of promising scientific and clinical advances to improve resuscitation outcomes in the out-of hospital setting. Having established unprecedented infrastructure to successfully accomplish this goal (using exception from informed consent under emergency circumstances) in 245 EMS agencies and nearly 35,000 EMS providers covering a population of over 22 million people throughout North America, ROC has already demonstrated its ability to rapidly advance the fields of emergency cardiac and trauma care. This proposal presents the rationale for a 6-year renewal of funding for ROC to continue to improve outcomes for these important national healthcare issues. Three of the specific aims of the Consortium are to further advance these fields by: 1) continuing to expand and investigate the cardiac arrest and traumatic injury Epistry database (already the largest available resource of its kind in the world), 2) complete ongoing cardiac arrest and traumatic injury studies in the next 18 months, and 3) implement and complete multiple additional cardiac arrest and traumatic injury clinical trials. The scientifically most premising trauma interventions, targeted for completion during the renewal period include, 1) immediate versus delayed intravenous fluid to decrease hemorrhage and subsequent reperfusion injury, 2) intravenous estrogen to decrease the magnitude of reperfusion injury, and 3) intravenous pentoxifylline to reduce release of inflammatory mediators and reactive oxidants after reperfusion. The scientifically most premising cardiac arrest interventions include: 1) continuous compressions versus standard CPR to improve survival, and 2) implementing therapeutic hypothermia immediately following restoration of circulation to reduce reperfusion injury and improve survival and qualitative outcome. The research design, rationale and techniques for achieving these proposals are specified in the application. Through this 6-year renewal, ROC will leverage its unparalleled infra-structure to significantly reduce morbidity and mortality from cardiac arrest and traumatic injury. Finally, the Toronto site also plans to expand training opportunities by applying for the Clinical Research Development Skills Core. Cardiovascular disease is the leading cause of death in the United States. Trauma is the leading cause of death among children, adolescents and young adults (ages 1-44) in North America. Improvements in survival and quality of life from continuing the Resuscitation Outcomes Consortium initiative will significantly impact these major national healthcare issues. (End of Abstract) Resume: In these excellent/very good applications the Resuscitation Outcomes Consortium (ROC) proposes to 1) continuing to expand and investigate the cardiac arrest and traumatic injury Epistry database, 2) complete ongoing cardiac arrest and traumatic injury studies, and 3) implement and complete multiple additional cardiac arrest and traumatic injury clinical trials. Strengths of the consortium are: the expertise of the principle investigators involved, the significance of ROC as a whole in improving out-of-hospital cardiopulmonary arrest (OOH-CA) and life-threatening traumatic injury (LTI), and the coordination / collaboration of the centers. There were several weaknesses that lowered enthusiasm. Some main ones that were discussed at length during review were: 1) Reviewers felt that trauma was underrepresented in the consortium and more outreach was needed to the trauma community; 2) There were concerns that when follow-up is done with patients on the phone and/or with materials that this needs to be done with languages other than English and Spanish since other languages are used in the US and Canada; 3) Concerns about the statement that in the prehospital setting providers call in to determine what study or study materials they are to administer to the patient- this was not considered effective or efficient; 4) There were significant concerns about the missing demographic data in the studies-especially those from Canada. Reviewers could not understand why in the very least a reasonable guess could not be made by the provider as to the race and gender of the patient and why a better method of tracking patients could not institute. In addition, there were comments about the focus of the Canadian centers only on city centers and not on rural areas and lack of outreach to the Canadian public. This consortium should significantly impact survival and quality of life in the US and Canada.