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

大出血后重新开始口服抗凝治疗的以患者为中心的方法

基本信息

批准号：
9032932
负责人：
Truman Milling
金额：
$ 13.47万
依托单位：
SETON HEALTHCARE
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-01 至 2021-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9032932
关键词：
Acute Address American American Heart Association Anticoagulant therapy Anticoagulants Anticoagulation Area Atrial Fibrillation Attitude Belief Benefits and Risks Berry Blood Coagulation Disorders Caring Characteristics Clinic Clinical Clinical Trials Coagulation Process Collection Communities Community Practice Community of Practice Complex Consent Data Data Quality Data Set Degree program Development Disease Dose Economics Educational Curriculum Electronics Enrollment Equilibrium European Event Exclusion Criteria Family Feedback Fostering Fright Future Gastrointestinal Hemorrhage Goals Health Health Sciences Healthcare Heart Diseases Heart Valve Prosthesis Hematological Disease Hemorrhage Hemostatic function Hospitals Individual Intervention Studies Intracranial Hemorrhages Master of Science Master&apos s Degree Measures Mentors Mentorship Methodology Mission Morbidity - disease rate National Heart, Lung, and Blood Institute Neurologic Oral Outcome Patients Pattern Pharmaceutical Preparations Phase Physicians Population Preparation Primary Health Care Process Prophylactic treatment Provider Publishing Randomized Recommendation Recurrence Research Research Design Research Infrastructure Research Personnel Risk Risk Assessment Sampling Scientist Side Stroke Surveys Survivors System Texas Thromboembolism Time Training Universities Variant Venous Warfarin Work austin base clinical investigation clinical practice design evidence base evidence based guidelines experience follow-up health economics inclusion criteria interest medical schools meetings mortality novel patient oriented patient population pilot trial prospective public health relevance randomized trial response therapy outcome tool trial design

项目摘要

DESCRIPTION (provided by applicant): 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 enrollin 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.

描述（由申请人提供）：抗凝剂导致的大出血是一种戏剧性的表现，由于担心引发另一次出血，人们对重新使用抗凝剂产生了偏见，在这种片面的风险评估中经常会忽视血栓栓塞性疾病的潜在威胁。迫切需要在出血和中风风险与前瞻性随机数据之间采取更平衡的方法。该提案与 NHLBI 的使命相关，因为它涉及心脏病，因为口服抗凝药物最常见的适应症是心房颤动，尽管它涉及的是抗凝治疗引起的医源性凝血病。，无论是胃肠道出血还是颅内出血，其目的是通过研究重大疾病后重新开始抗凝治疗的风险/益处来增强这些疾病患者的健康。它的目标立即转化为临床实践。它与私营非营利组织 Seton Healthcare Family 和位于奥斯汀的新德克萨斯大学戴尔医学院合作，创建并支持强大的协作研究基础设施。目前还没有关于何时重新启动的循证指南。大出血后使用华法林，更不用说越来越多地使用新型口服抗凝剂（NOAC）。本申请的总体目标是阐明一项研究计划，为大出血后重新开始抗凝治疗的临床决策提供信息。确立 Milling 博士在该领域的独立影响力研究员。 Milling 博士将在圣安东尼奥德克萨斯大学健康科学中心攻读正式的硕士学位课程：临床研究理学硕士。他还将接受广泛的沉浸式培训。 Milling 博士将在止血和凝血、多中心临床试验的设计和实施、适应性试验设计领域的概念培训以及健康经济学方面得到 Steven Warach 和 Scott Berry Todd 博士的精心指导。 Olmstead 和 Jerrold Levy 利用正式培训课程和非正式会议框架，借鉴他们丰富多样的经验和指导，进行三阶段的研究设计，包括开发国家临床试验实践调查工具（调查）。患者、PCP 和心脏病专家），为更大规模的多中心、适应性、“时间剂量”临床试验和未来的 R01 提交奠定基础，以找到重新启动的理想时间大出血后口服抗凝剂可平衡复发性出血的风险与血栓栓塞性疾病的风险。