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

描述(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，对老年人的影响不成比例。老年人也不成比例地受到抗凝(AC)药物需求的影响，因为这些药物是为了预防患有房颤、人工心脏瓣膜、深静脉血栓形成和缺血等情况的患者的血栓栓塞。 中风，尤其是在老年人中流行。因此，许多患有脑外伤的老年患者在脑损伤时服用AC药物也就不足为奇了。创伤性脑损伤同时需要AC治疗，这构成了一个严重的临床难题：是否应该在脑损伤后恢复AC治疗，如果是，何时恢复？目前的临床指南没有提供一般创伤事件后，尤其是老年人脑外伤后恢复AC治疗的安全性或时机的指导。该应用程序的目的是描述与脑外伤后恢复使用AC药物相关的实践模式，并量化脑损伤后恢复使用AC药物对老年人预后的影响。我们的理论基础是，脑外伤后恢复AC治疗与相互竞争的有益和不利结果相关，而且关于收益-风险比的量化信息很少。为了实现研究目标，我们提出了两个研究目标，使用回溯性队列设计并结合最新的统计方法来分析联邦医疗保险的管理数据：1)确定与在脑外伤发作时接受长期AC治疗的联邦医疗保险受益人恢复抗凝治疗时间相关的因素；2)评估与脑外伤后早期恢复、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)之间的平衡。这项拟议的工作具有创新性，因为它利用了我们独特的经验和对Medicare Part D药物数据的访问，以回答一个重要的临床问题，有可能显著改善老年人严重伤害后的预后。这项拟议研究的预期结果是，通过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，以及在脑外伤后恢复AC药物治疗的好处和风险。这项研究的结果将支持建立循证指南，以改善老年人脑外伤日益严重的问题的管理，特别是那些患有需要抗凝的并存疾病的老年人。此外，这些结果将为未来多中心随机对照试验的设计提供参考，该试验将研究老年人脑外伤后AC恢复的影响。 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，对老年人的影响不成比例。老年人也不成比例地受到血液稀释剂药物需求的影响，因为这些药物经常被用来预防血栓和血栓，这种情况在老年人中特别常见。脑损伤与血液稀释药物的需求结合在一起构成了一个严重的临床困境：脑损伤后是否应该恢复血液稀释剂，如果应该，何时恢复？这项研究将提供关于血液稀释剂的益处(预防中风和其他血栓)和风险(出血)的有价值的信息，这些药物在一组有脑外伤病史并需要血液稀释剂药物的老年人中使用。

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.