A Patient Centered Approach to Restarting Oral Anticoagulant Therapy After Major Hemorrhage

项目摘要/摘要 抗凝剂的大出血是一种戏剧性的表现，它造成了对重新启动的偏见 为了避免再次出血，使用了抗凝剂。在这种片面的情况下，经常会迷失什么 风险评估是血栓栓塞性疾病的潜在威胁，患者因此而 一开始就是抗凝的。在出血风险和中风风险之间更平衡的方法--以及 作为其基础的前瞻性随机数据是迫切需要的。这项提议与 NHLBI治疗心脏病，因为口服抗凝最常见的适应症是心房 纤颤。它处理血液疾病，尽管是由抗凝治疗引起的医源性凝血障碍。它 讨论出血的临床环境，包括消化道出血和颅内出血。它的目标是 通过研究重新开始抗凝的风险/益处来提高这些疾病患者的健康 在大出血后。它的目标是立即转化为临床实践。它促进了培训和 指导一位新兴的科学家和医生，它创建并支持一项强大的协作研究 基础设施，与私人非营利性组织Seton Healthcare Family和新的华盛顿大学合作 位于奥斯汀的德克萨斯州戴尔医学院。 对于大出血后何时重新启动华法林，目前还没有循证指南，更不用说了 新型口服抗凝剂(NOAC)越来越多地被使用。此应用程序的总体目标是 阐明一项研究计划，为临床决定在大出血后重新开始抗凝提供信息 将使米林博士成为这一领域的独立、有影响力的研究员。米林博士将参加一项正式的 硕士学位项目：德克萨斯大学临床研究理学硕士 圣安东尼奥科学中心。他还将接受广泛和身临其境的止血培训和 凝血、多中心临床试验的设计和实施、适应性试验领域的概念培训 设计和健康经济学。米林博士将接受史蒂文·沃拉赫博士、斯科特·贝里博士的精心指导 托德·奥姆斯特德和杰罗尔德·利维利用正式培训课程和非正式会议框架 从他们广泛和多样化的经验和指导中吸取教训。米林博士将进行三个阶段的 研究设计，包括为临床试验开发国家实践调查工具(调查 患者、儿科医生和心脏病专家)，为更大的多中心、自适应的“时间剂量”奠定了基础 临床试验和未来的R01提交，以找到理想的时间重新开始口服抗凝剂后，主要 在复发出血和血栓栓塞病风险之间取得平衡的出血。

Project Summary/Abstract Major hemorrhage on anticoagulants is a dramatic presentation that creates a bias against restarting the anticoagulant for fear of precipitating another hemorrhage. What often gets lost in this one-sided assessment of risk is the underlying threat of thromboembolic disease, for which the patient was anticoagulated to begin with. A more balanced approach between the risk of hemorrhage and stroke -- and prospective randomized data on which to base it -- is direly needed. This proposal is relevant to the mission of NHLBI as it deals with heart disease, since the most common indication for oral anticoagulation is atrial fibrillation. It deals with blood disease, albeit an iatrogenic coagulopathy caused by anticoagulation therapy. It deals with the clinical setting of bleeding, both in gastrointestinal bleeding and intracranial hemorrhage. It aims to enhance the health of patients with these diseases by studying the risk/benefit of restarting anticoagulation after major hemorrhage. Its goals are immediately translational into clinical practice. It fosters training and mentoring of an emerging scientist and physician, and it creates and supports a robust, collaborative research infrastructure in partnership with the private non-profit Seton Healthcare Family and the new University of Texas Dell Medical School in Austin. There are no evidence-based guidelines on when to restart warfarin after major hemorrhage, much less the Novel Oral Anticoagulants (NOACs) increasingly being used. The overall goal of this application is to elucidate a research plan to inform the clinical decision to restart anticoagulation after major hemorrhage that will establish Dr. Milling as an independent impactful researcher in this field. Dr. Milling will enroll in a formal master's degree program: Masters of Science in Clinical Investigations at the University of Texas Health Science Center – San Antonio. He will also undergo extensive and immersive training in hemostasis and coagulation, the design and conduct of multicenter clinical trials, conceptual training in the field of adaptive trial design, and health economics. Dr. Milling will receive careful mentorship from Drs. Steven Warach, Scott Berry Todd Olmstead and Jerrold Levy utilizing both formal training curriculum and informal meeting frameworks to draw from their extensive and diverse experience and guidance. Dr. Milling will conduct a three-phased research design, including the development of a National Practice Survey Tool for Clinical Trials (survey of patients, PCPs, and Cardiologists), laying the ground work for a larger multicenter, adaptive, “time dose” clinical trial and a future R01 submission, to find the ideal time to restart oral anticoagulants after a major hemorrhage that balances the risk of recurrent hemorrhage with the risk of thromboembolic disease.