Resuscitation Outcomes Consortium Regional Clinical Center-DFW Center for Resusci

复苏结果联盟区域临床中心-DFW 复苏中心

• 批准号: 8036071
• 负责人: AHAMED H IDRIS
• 金额: $ 15.85万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8036071
• 关键词: Adolescent; Age; Blood Circulation; Canada; Cardiac; Cardiopulmonary Arrest; Cardiovascular Diseases; Caring; Cause of Death; Child; Cities; Clinical; Clinical Research; Clinical Trials; Communities; Conduct Clinical Trials; Coordination and Collaboration; Data; Data Coordinating Center; Databases; Emergency Situation; Emergency medical service; Enrollment; Estrogens; Funding; Gender; Goals; Healthcare; Heart Arrest; Hemorrhage; Hospitals; IV Fluid; Inflammation Mediators; Informed Consent; Injury; Institutes; Intervention; Intravenous; Language; Length; Life; Methods; Morbidity - disease rate; North America; Observational Study; Outcome; Oxidants; Patients; Pentoxifylline; Performance; Phase; Population; Process; Provider; Published Comment; Quality of life; Race; Reperfusion Injury; Reperfusion Therapy; Research; Research Design; Research Infrastructure; Research Personnel; Resources; Resuscitation; Series; Site; Specific qualifier value; Structure; Techniques; Telephone; Therapeutic; Training; Translations; Trauma; United States; abstracting; base; clinical practice; collaborative trial; design; follow-up; improved; mortality; natural hypothermia; outreach; randomized trial; research and development; restoration; rural area; skills; young adult

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.

描述(由申请人提供)：复苏结果联盟(ROC)由9个地区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，即快速转化有前景的科学和临床进展，以改善院外环境下的复苏结果。中华民国在北美2200多万人口的245家EMS机构和近35,000家EMS提供者中建立了史无前例的基础设施，以成功实现这一目标(在紧急情况下使用知情同意除外)，中华民国已经展示了其快速推进心脏和创伤急救领域的能力。这项提案提出了为中华民国延长6年资金的理由，以继续改善这些重要的国家医疗保健问题的结果。该联盟的三个具体目标是通过以下方式进一步推进这些领域：1)继续扩大和调查心脏骤停和创伤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研究，以及3)实施和完成多个额外的心脏骤停和创伤临床试验。科学上最有前提的创伤干预措施，目标是在更新期内完成，包括：1)立即而不是延迟静脉输液以减少出血和随后的再灌注损伤，2)静脉注射雌激素以降低再灌注损伤的程度，以及3)静注己酮可可碱以减少再灌注后炎症介质和反应性氧化剂的释放。最科学的心脏骤停干预措施包括：1)与标准CPR相比，持续按压以提高存活率，以及2)在恢复循环后立即实施治疗性低温，以减少再灌注损伤，提高存活率和质量。申请书中具体说明了实现这些建议的研究设计、理论基础和技术。透过这项为期6年的续期，中华民国将利用其无与伦比的基础设施，显著降低心脏骤停和创伤的发病率和死亡率。最后，多伦多的网站还计划通过申请临床研究开发技能核心来扩大培训机会。在美国，心血管疾病是主要的死亡原因。创伤是北美儿童、青少年和青壮年(1-44岁)的主要死亡原因。持续的复苏结果联盟倡议在生存和生活质量方面的改善将对这些重大的国家医疗保健问题产生重大影响。(摘要结束) 摘要：在这些优秀/非常好的应用中，复苏结果联盟(ROC)建议1)继续扩大和调查心脏骤停和创伤Epistry数据库，2)完成正在进行的心脏骤停和创伤研究，以及3)实施和完成多个额外的心脏骤停和创伤临床试验。该联盟的优势是：相关主要调查人员的专业知识，中华民国在改善院外心肺骤停(ONG-CA)和危及生命的创伤(LTI)方面的整体意义，以及各中心的协调/合作。有几个弱点降低了人们的热情。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合体中的代表性不足，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，因为其他语言在美国和加拿大使用；3)对以下声明的担忧：在院前环境中，提供者打电话来确定他们应该向患者提供什么研究或研究材料--这被认为不有效或效率不高；4)对研究中缺失的人口数据--特别是来自加拿大的数据--存在重大担忧。审查者不能理解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，为什么不能建立更好的跟踪患者的方法。此外，有人评论说，加拿大的中心只关注城市中心，而不是农村地区，缺乏对加拿大公众的接触。这个联盟应该会对美国和加拿大的生存和生活质量产生重大影响。