Department of Perioperative Medicine, Population Health Research Institute, Hamilton, Ontario, Canada.
Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2019 May 1;9(4):e028537. doi: 10.1136/bmjopen-2018-028537.
Annually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%-10% at 30 days and 10%-20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial-HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.
HIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.
All centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.
NCT02027896; Pre-results.
每年都有数百万成年人遭受髋部骨折。髋部骨折后 30 天的死亡率为 7%-10%，90 天的死亡率为 10%-20%。观察数据表明，早期手术可以改善髋部骨折患者的这些结果。我们设计了一项临床试验——髋部骨折加速手术治疗和护理追踪（HIP ATTACK），以确定与标准护理相比，加速手术对髋部骨折患者 90 天全因死亡率和主要围手术期并发症的影响。
HIP ATTACK 是一项多中心、国际、平行组随机对照试验（RCT），将纳入年龄≥45 岁且因低能量机制导致需要手术的髋部骨折患者。患者被随机分为加速医疗评估和手术修复（目标在 6 小时内）或标准护理。主要复合终点为（1）全因死亡率和（2）90 天随机分组后主要围手术期并发症（即死亡率和非致命性心肌梗死、肺栓塞、肺炎、败血症、中风以及危及生命和大出血）的复合终点。所有患者将随访 1 年。我们将纳入 3000 例患者。
所有中心在为患者随机分组前都获得了伦理批准。所有患者在随机分组前都需要书面知情同意。HIP ATTACK 是首个旨在检查加速手术是否能改善髋部骨折患者结局的大型国际试验。传播计划包括在有政策影响力的期刊上发表研究结果、会议演讲、与有影响力的医学组织合作以及通过多媒体资源提高公众意识。
NCT02027896；预结果。
