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

• 批准号: 9765368
• 负责人: Truman Milling
• 金额: $ 13.45万
• 依托单位: SETON HEALTHCARE
• 依托单位国家: 美国
• 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/9765368
• 关键词: Acute; Address; American; American Heart Association; American Stroke Association; Anticoagulant therapy; Anticoagulants; Anticoagulation; Area; Atrial Fibrillation; Attitude; Belief; Benefits and Risks; Berry; Blood Coagulation Disorders; Brain hemorrhage; Caring; Characteristics; Clinic; Clinical; Clinical Trials; Coagulation Process; Collection; Communities; Community Practice; Complex; Consent; Data; Data Quality; Data Set; Degree program; Development; Disease; Dose; Economics; Educational Curriculum; Enrollment; Equilibrium; European; Event; Exclusion Criteria; Exposure to; Family; Feedback; Fostering; Fright; Future; Gastrointestinal Hemorrhage; Goals; Guidelines; Health; Health Sciences; Healthcare; Heart Diseases; Heart Valve Prosthesis; Hematological Disease; Hemorrhage; Hemostatic function; Hospitals; Iatrogenesis; Immersion Investigative Technique; Individual; Intervention Studies; Intracranial Hemorrhages; Master of Science; Master' s Degree; Measures; Mentors; Mentorship; Methodology; Mission; Morbidity - disease rate; Multi-Institutional Clinical Trial; National Heart, Lung, and Blood Institute; Neurologic; Oral; Outcome; Patients; Pattern; Pharmaceutical Preparations; Phase; Physicians; Population; Preparation; Privatization; 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; care providers; 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; stroke risk; therapy outcome; tool; trial design

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）：抗凝剂治疗后的大出血是一种戏剧性表现，由于担心引发另一次出血，导致对重新开始抗凝剂治疗的偏倚。在这种片面的风险评估中，经常会忽略血栓栓塞性疾病的潜在威胁，而患者开始就是因为血栓栓塞性疾病而接受抗凝治疗的。迫切需要一种在出血和卒中风险与前瞻性随机数据之间更平衡的方法。该建议与NHLBI的使命相关，因为它涉及心脏病，因为口服抗凝剂最常见的适应症是房颤。它涉及血液疾病，尽管是由抗凝治疗引起的医源性凝血病。它涉及出血的临床背景，包括消化道出血和颅内出血。其目的是通过研究大出血后重新开始抗凝治疗的风险/获益来增强这些疾病患者的健康。其目标是立即转化为临床实践。它促进培训和指导 该公司是一家新兴的科学家和医生，它与私人非营利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。关于大出血后何时重新开始华法林治疗尚无循证指南，更不用说越来越多地使用新型口服抗凝剂（NOAC）了。本申请的总体目标是阐明一项研究计划，以告知在大出血后重新开始抗凝治疗的临床决策，这将使Milling博士成为该领域有影响力的独立研究人员。Milling博士将在圣安东尼奥的德克萨斯大学健康科学中心攻读正式的临床研究硕士学位。他还将接受止血和凝血方面的广泛和身临其境的培训，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卫生经济学。Milling博士将接受Steven Warach博士、Scott Berry托德Olmstead博士和Jerrold Levy博士的悉心指导，利用正式培训课程和非正式会议框架，借鉴他们广泛而多样的经验和指导。Milling博士将进行三阶段研究设计，包括开发临床试验的国家实践调查工具（对患者、PCP和心脏病专家的调查），为更大的多中心、自适应、“时间剂量”临床试验和未来的R 01提交奠定基础，以找到重新开始的理想时间。 大出血后口服抗凝剂，平衡复发性出血风险和血栓栓塞性疾病风险。