Long-Term Anticoagulation Therapy After Traumatic Brain Injury in Older Adults

老年人脑外伤后的长期抗凝治疗

• 批准号: 8352843
• 负责人: ILENE HARRIS
• 金额: $ 23.03万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8352843
• 关键词: Accounting; Affect; Aging; Anatomic Sites; Anticoagulants; Anticoagulation; Atrial Fibrillation; Benefits and Risks; Brain Injuries; Characteristics; Clinical; Coagulation Process; Complex; Critical Illness; Data; Databases; Deep Vein Thrombosis; Elderly; Embolism; Epidemic; Epidemiology; Equilibrium; Event; Future; Geographic Locations; Geriatrics; Goals; Grant; Guidelines; Health; Health system; Heart Valve Prosthesis; Hemorrhage; Injury; Intervention Studies; Ischemic Stroke; Knowledge; Medicare; Medication Management; Methods; NIH Program Announcements; Outcome; Patients; Pattern; Pharmaceutical Preparations; Pharmacoepidemiology; Prevention; Probability; Prospective Studies; Provider; Randomized Controlled Trials; Recording of previous events; Research; Risk; Safety; Selection for Treatments; Severities; Statistical Methods; Stroke prevention; Thromboembolism; Time; Trauma; Traumatic Brain Injury; Work; adverse outcome; base; beneficiary; cohort; design; evidence based guidelines; experience; follow-up; improved; innovation; medical specialties; meetings; older patient; prevent; programs; risk benefit ratio; skills; therapy outcome

DESCRIPTION (provided by applicant): Traumatic brain injury (TBI), often referred to as the "silent epidemic," is an important health problem that disproportionately affects older adults. Older adults also are disproportionately affected by the need for anticoagulation (AC) medications since these medications are given to prevent thromboembolism in patients with conditions such as atrial fibrillation, prosthetic heart valves, deep vein thrombosis, and ischemic stroke, which are especially prevalent among older adults. Thus, it is not surprising that many older patients presenting with TBI were taking AC medication at the time of their brain injury. The co-occurrence of TBI with the need for AC therapy poses a serious clinical dilemma: Should AC therapy be resumed after a TBI, and if so, when? Current clinical guidelines do not provide guidance regarding the safety or timing of resumption of AC therapy after traumatic events in general, or specifically after TBI in older adults. The objectives of this application are to characterize practice patterns related to resumption of AC medication after a TBI and to quantify the impact of post-TBI resumption of AC medication on outcomes in older adults. Our rationale is that resumption of AC therapy after a TBI is associated with competing beneficial and adverse outcomes, and there is a paucity of information about quantification of the benefit-risk ratio. To achieve the study objectives, we propose two study aims using a retrospective cohort design and incorporating state-of-the art statistical methods to analyze Medicare administrative data: 1) To identify factors associated with time to resumption of anticoagulation therapy among Medicare beneficiaries who were receiving long-term AC therapy at the time of a TBI episode; and 2) To evaluate the balance of beneficial outcomes (prevention of thromboembolism) and adverse outcomes (hemorrhage) associated with early resumption, delayed resumption, or no resumption of AC therapy after a TBI. This proposed work is innovative because it capitalizes on our unique experience and access to the Medicare Part D drug data to answer an important clinical question with the potential to significantly improve outcomes following serious injury in older adults. The expected outcomes of the proposed study are increased knowledge about current "real world" practice patterns, using a nationally representative database, and the benefits and risks of resumption of AC medication post-TBI. The results of this study will support creation of evidence-based guidelines for improving the management of the increasing problem of TBI in older adults, especially those with coexisting conditions that require anticoagulation. I addition, the results will inform the design of future multicenter randomized controlled trials tha study the impact of resumption of AC following TBI in older adults. PUBLIC HEALTH RELEVANCE: Traumatic brain injury (TBI), often referred to as the "silent epidemic," is an important health problem that disproportionately affects older adults. Older adults also are disproportionately affected by the need for blood- thinner medications since these medications are frequently given to prevent clots and embolism in patients with conditions which are especially common among older adults. The combination of TBI with the need for blood-thinning medication poses a serious clinical dilemma: Should blood-thinners be resumed after a TBI, and if so, when? This study will provide valuable information about the benefits (prevention of strokes and other clots) and risks (bleeding) of blood-thinner medications in a cohort of older adults with a history of TBI and who require blood-thinner medication.

描述（由申请人提供）：创伤性脑损伤（TBI），通常被称为“沉默的流行病”，是一个重要的健康问题，不成比例地影响老年人。老年人也不成比例地受到抗凝（AC）药物需求的影响，因为这些药物用于预防患有诸如心房颤动、人工心脏瓣膜、深静脉血栓形成和缺血性心脏病的患者的血栓栓塞。 中风，在老年人中尤其普遍。因此，许多患有TBI的老年患者在脑损伤时服用AC药物并不奇怪。TBI与AC治疗需求的共同发生造成了严重的临床困境：TBI后是否应该恢复AC治疗，如果是，何时恢复？目前的临床指南没有提供关于一般创伤事件后，或特别是老年人TBI后恢复AC治疗的安全性或时间的指导。本申请的目的是表征与TBI后恢复AC药物治疗相关的实践模式，并量化TBI后恢复AC药物治疗对老年人结局的影响。我们的理论基础是，TBI后恢复AC治疗与竞争性有益和不良结局相关，并且缺乏有关获益风险比量化的信息。为了达到研究目的，我们提出了两个研究目的，采用回顾性队列设计，并结合最先进的统计方法来分析医疗保险管理数据：1）确定与TBI发作时接受长期AC治疗的医疗保险受益人恢复抗凝治疗时间相关的因素;以及2）评估TBI后与AC治疗的早期恢复、延迟恢复或不恢复相关的有益结果（血栓栓塞的预防）和不良结果（出血）的平衡。这项拟议的工作是创新的，因为它利用了我们独特的经验和对医疗保险D部分药物数据的访问，以回答一个重要的临床问题，有可能显着改善老年人严重受伤后的结果。拟议研究的预期结果是增加对当前“真实的世界”实践模式的了解，使用具有全国代表性的数据库，以及TBI后恢复AC药物治疗的益处和风险。这项研究的结果将支持建立循证指南，以改善老年人日益严重的TBI问题的管理，特别是那些需要抗凝治疗的共存疾病。此外，该结果将为将来设计研究老年人TBI后恢复AC的影响的多中心随机对照试验提供信息。 公共卫生相关性：创伤性脑损伤（TBI），通常被称为“沉默的流行病”，是一个重要的健康问题，不成比例地影响老年人。老年人也不成比例地受到血液稀释剂药物需求的影响，因为这些药物经常用于预防老年人中特别常见的患者的血栓和栓塞。TBI与血液稀释药物的需求相结合，构成了一个严重的临床困境：TBI后是否应该恢复血液稀释剂，如果是，什么时候恢复？这项研究将提供有关血液稀释剂药物在有TBI病史和需要血液稀释剂药物的老年人队列中的益处（预防中风和其他血栓）和风险（出血）的有价值的信息。