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

项目总结/摘要 抗凝剂上的大出血是一个戏剧性的介绍，创造了对重新开始的偏见 抗凝剂以防再次出血在这种片面的 风险评估是血栓栓塞性疾病的潜在威胁， 开始抗凝。出血和中风风险之间更平衡的方法- 作为其基础的前瞻性随机数据是迫切需要的。这项建议与联合国的使命有关， NHLBI，因为它涉及心脏病，因为口服抗凝剂的最常见适应症是心房肌 纤维性颤动它涉及血液疾病，尽管是由抗凝治疗引起的医源性凝血病。它 涉及出血的临床情况，包括消化道出血和颅内出血。它旨在 通过研究重新开始抗凝治疗的风险/获益来改善这些疾病患者的健康 在大出血后其目标是立即转化为临床实践。它促进培训， 一个新兴的科学家和医生的指导，它创建和支持一个强大的，合作研究 基础设施与私人非营利西顿医疗保健家庭和新的大学合作， 德克萨斯州奥斯汀戴尔医学院。 对于大出血后何时重新开始华法林治疗，目前还没有循证指南， 新型口服抗凝剂（NOAC）的使用越来越多。此应用程序的总体目标是 阐明一项研究计划，以告知在严重出血后重新开始抗凝治疗的临床决定， 将使Milling博士成为该领域有影响力的独立研究人员。米勒博士将参加一个正式的 硕士学位课程：得克萨斯大学健康科学临床研究硕士 科学中心-圣安东尼奥。他还将接受广泛和身临其境的止血培训， 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 设计和卫生经济学。Milling博士将接受Steven Warach博士，Scott Berry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， 从他们丰富多样的经验和指导中汲取经验。米勒博士将进行一个三阶段的 研究设计，包括开发临床试验国家实践调查工具（临床试验调查） 患者、PCP和心脏病专家），为更大的多中心、自适应、“时间剂量”奠定基础 临床试验和未来的R 01提交，以找到在重大事件发生后重新开始口服抗凝剂的理想时间。 平衡复发性出血风险和血栓栓塞性疾病风险的出血。

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.