CMAJ. 2014 Jan 7;186(1):E52-60. doi: 10.1503/cmaj.130901. Epub 2013 Nov 18.
A hip fracture causes bleeding, pain and immobility, and initiates inflammatory, hypercoagulable, catabolic and stress states. Accelerated surgery may improve outcomes by reducing the duration of these states and immobility. We undertook a pilot trial to determine the feasibility of a trial comparing accelerated care (i.e., rapid medical clearance and surgery) and standard care among patients with a hip fracture.
Patients aged 45 years or older who, during weekday, daytime working hours, received a diagnosis of a hip fracture requiring surgery were randomly assigned to receive accelerated or standard care. Our feasibility outcomes included the proportion of eligible patients randomly assigned, completeness of follow-up and timelines of accelerated surgery. The main clinical outcome, assessed by data collectors and adjudicators who were unaware of study group allocations, was a major perioperative complication (i.e., a composite of death, preoperative myocardial infarction, myocardial injury after noncardiac surgery, pulmonary embolism, pneumonia, stroke, and life-threatening or major bleeding) within 30 days of randomization.
Of patients eligible for inclusion, 80% consented and were randomly assigned to groups (30 to accelerated care and 30 to standard care) at 2 centres in Canada and 1 centre in India. All patients completed 30-day follow-up. The median time from diagnosis to surgery was 6.0 hours in the accelerated care group and 24.2 hours in the standard care group (p < 0.001). A major perioperative complication occurred in 9 (30%) of the patients in the accelerated care group and 14 (47%) of the patients in the standard care group (hazard ratio 0.60, 95% confidence interval 0.26-1.39).
These results show the feasibility of a trial comparing accelerated and standard care among patients with hip fracture and support a definitive trial.
ClinicalTrials.gov, no. NCT01344343.
髋部骨折会导致出血、疼痛和活动受限，并引发炎症、高凝、分解代谢和应激状态。加速手术可以通过减少这些状态和活动受限的持续时间来改善预后。我们进行了一项试点试验，以确定比较髋部骨折患者加速护理（即快速医疗清除和手术）与标准护理的试验的可行性。
在工作日白天工作时间内，年龄在 45 岁或以上的髋部骨折需要手术的患者被随机分配接受加速护理或标准护理。我们的可行性结果包括随机分配的合格患者比例、随访的完整性和加速手术的时间安排。主要临床结局由数据收集员和裁判评估，他们不知道研究组的分配，是术后 30 天内的主要围手术期并发症（即死亡、术前心肌梗死、非心脏手术后心肌损伤、肺栓塞、肺炎、中风和危及生命或大出血）。
在符合纳入条件的患者中，80%的患者同意并在加拿大的 2 个中心和印度的 1 个中心被随机分配到加速护理组（30 例）和标准护理组（30 例）。所有患者均完成了 30 天的随访。加速护理组从诊断到手术的中位时间为 6.0 小时，标准护理组为 24.2 小时（p < 0.001）。加速护理组有 9 例（30%）患者发生主要围手术期并发症，标准护理组有 14 例（47%）患者发生（风险比 0.60，95%置信区间 0.26-1.39）。
这些结果表明，比较髋部骨折患者加速护理与标准护理的试验是可行的，并支持进行一项确定性试验。
ClinicalTrials.gov，编号 NCT01344343。
