Resuscitation Outcomes Consortium (ROC) Regional Clinical Center-Seattle-King

复苏结果联盟 (ROC) 地区临床中心 - 西雅图 - 金

• 批准号: 8607978
• 负责人: Peter James Kudenchuk
• 金额: $ 12.35万
• 依托单位: UNIVERSITY OF WASHINGTON
• 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/8607978
• 关键词: Adolescent and Young Adult; Age; Blood Circulation; Canada; Cardiac; Cardiopulmonary Arrest; Cardiovascular Diseases; Caring; Cause of Death; Child; Cities; Clinical; Clinical Research; Clinical Trials; Communities; 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; trauma care

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个区域临床中心和一个数据和协调中心组成，正在开展多项合作试验，以实现其快速转化有前景的科学和临床进展的长期目标，以改善院外环境中的复苏结果。为了成功实现这一目标（在紧急情况下使用知情同意例外），ROC在北美245家EMS机构和近35,000家EMS供应商中建立了前所未有的基础设施，覆盖了2200多万人口，ROC已经证明了其快速推进急诊心脏和创伤护理领域的能力。该提案提出了一个为期6年的资金更新的基本原理，ROC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)继续扩展和调查心脏骤停和创伤性损伤数据库（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)实施和完成多个额外的心脏骤停和创伤性损伤临床试验。科学上最重要的创伤干预措施，目标是在更新期间完成，包括：1)立即静脉输液与延迟静脉输液，以减少出血和随后的再灌注损伤；2)静脉注射雌激素，以减少再灌注损伤的程度；3)静脉注射自酮茶碱，以减少再灌注后炎症介质和活性氧化剂的释放。科学上最有效的心脏骤停干预措施包括：1)持续按压与标准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，提高生存率和定性结果。研究设计、基本原理和实现这些建议的技术在申请中详细说明。通过这项为期6年的更新，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，心血管疾病是导致死亡的主要原因。创伤是北美儿童、青少年和青壮年（1-44岁）死亡的主要原因。继续实施复苏结果联盟倡议，将大大改善生存和生活质量，对这些主要的国家卫生保健问题产生重大影响。（摘要结束）