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: 8516956
• 负责人: LINDA J SIMONI-WASTILA
• 金额: $ 18.13万
• 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/8516956
• 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.

描述（由申请人提供）：创伤性脑损伤（TBI）通常被称为“无声流行病”，是一个重要的健康问题，对老年人的影响尤为严重。老年人也受到抗凝 (AC) 药物需求的不成比例的影响，因为这些药物用于预防患有心房颤动、人工心脏瓣膜、深静脉血栓和缺血性心脏病等疾病的患者的血栓栓塞。 中风，在老年人中尤其常见。因此，许多患有 TBI 的老年患者在脑损伤时服用 AC 药物也就不足为奇了。 TBI 与 AC 治疗同时发生带来了严重的临床困境：TBI 后是否应该恢复 AC 治疗？如果需要，何时恢复？目前的临床指南并未就一般创伤事件后，或特别是老年人 TBI 后恢复 AC 治疗的安全性或时机提供指导。本应用的目的是描述与 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。我们的理由是，TBI 后恢复 AC 治疗与相互竞争的有益和不良结果相关，并且缺乏关于量化获益风险比的信息。为了实现研究目标，我们提出了两个研究目标，使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）确定在 TBI 发作时接受长期 AC 治疗的医疗保险受益人中与恢复抗凝治疗时间相关的因素； 2) 评估与 TBI 后早期恢复、延迟恢复或不恢复 AC 治疗相关的有益结果（预防血栓栓塞）和不良结果（出血）的平衡。这项拟议的工作具有创新性，因为它利用我们独特的经验和对 Medicare D 部分药物数据的访问来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使用具有全国代表性的数据库，增加对当前“现实世界”实践模式的了解，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制定基于证据的指南，以改善老年人日益严重的 TBI 问题的管理，特别是那些患有需要抗凝治疗的共存疾病的老年人。此外，这些结果将为未来多中心随机对照试验的设计提供信息，这些试验研究 TBI 后恢复 AC 对老年人的影响。