■损伤后可预防死亡的最常见原因是出血。复苏血管内球囊闭塞主动脉旨在提供更早,临时出血控制,为了方便转移到手术室或介入放射学套件进行明确的止血。
比较急诊科放血出血患者的标准护理加复苏腔内球囊阻断主动脉与标准护理。
■务实,多中心,贝叶斯,group-sequential,启用注册表,开放标签,平行组随机对照试验,以确定标准护理加复苏血管内球囊闭塞主动脉的临床和成本效益,与标准护理相比。
■英国主要创伤中心。
■年龄在16岁或以上且已证实或怀疑有危及生命的躯干出血的创伤患者被认为可接受主动脉内球囊闭塞复苏辅助治疗。
■参与者被随机分配到:标准护理,正如预期的那样,在一个主要的创伤中心标准护理加上复苏腔内球囊闭塞主动脉。
■主要:90天的死亡率。次要:6个月时的死亡率,在医院里,24、6和3小时内;需要出血控制程序,开始出血程序的时间,并发症,住院时间(无住院和重症监护病房天数),血液产品使用。卫生经济:英国国民卫生服务的预期成本,生命年和质量调整生命年,模仿一生的地平线。
■病例报告表,创伤审计和研究网络注册,NHS数字(医院事件统计和国家统计局数据)。
■90例患者被纳入:46例随机接受标准治疗加主动脉血管内球囊闭塞复苏治疗,44例接受标准治疗。与标准护理组(42%)相比,标准护理加复苏性血管内球囊闭塞的主动脉组(54%)在90天的死亡率更高。比值比为1.58(95%可信区间0.72至3.52)。比值比>1的后验概率为86.9%(表明主动脉血管内球囊复苏闭塞导致死亡的几率增加)。当使用热情的先验或根据基线特征调整估计值时,总体效果没有变化。对于次要结局(3、6和24小时死亡率),与主要结局相比,标准治疗加复苏腔内球囊阻断主动脉有害的后验概率较高.考虑并发事件的其他分析并未改变任何时间点死亡率估计值的方向。与标准护理组相比,标准护理加复苏性血管内球囊闭塞的主动脉组因出血死亡更为常见。没有严重的不良装置影响。复苏血管内球囊闭塞主动脉的成本较低(概率99%),由于竞争性死亡风险,但在寿命质量调整寿命年方面的效果也大大降低(概率91%)。
■研究的规模反映了英国外伤性出血出血的相对频率。组间有一些基线不平衡,但调整后的分析对估计值影响不大.
■这是首次在放血出血的标准治疗中增加复苏性血管内球囊闭塞主动脉的随机试验。所有分析表明,标准护理加复苏性血管内球囊闭塞主动脉的策略可能有害。
■在院前设置中复苏血管内球囊闭塞主动脉的作用(如果有的话)尚不清楚。可能需要进一步研究以阐明其潜力(或不)。
■本试验注册为ISRCTN16184981。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖项编号:14/199/09)资助,并在《卫生技术评估》中全文发布。28号54.有关更多奖项信息,请参阅NIHR资助和奖励网站。
创伤(身体伤害)是导致死亡和残疾的主要原因。受伤后可预防死亡的最常见原因是不受控制的出血。主动脉的复苏血管内球囊闭塞是一种技术,其中小球囊在主动脉(主血管)中膨胀,目的是限制失血,直到可以进行手术以止血。在这项研究中,这是该技术世界上第一个随机试验,我们调查了在主要创伤中心接受的标准治疗中加入复苏性血管内球囊阻断主动脉是否降低了危及生命的未控制出血的创伤患者的死亡风险.这项研究在英国的16个主要创伤中心进行。90例确诊或怀疑出血不受控制的成年创伤患者参加,随机分为两组:(1)接受标准护理的患者和(2)接受标准护理加复苏性血管内球囊闭塞主动脉的患者。我们使用从国家卫生服务和创伤审计研究网络注册表中常规收集的数据跟踪参与者6个月。我们还在6个月时联系了幸存的患者,询问他们的生活质量。在标准护理组中,42%的参与者在受伤后90天内死亡,而在标准护理加复苏血管内球囊闭塞的主动脉组中,有54%的参与者死亡。在所有其他时间点(3、6和24小时,主动脉组的标准护理加复苏血管内球囊闭塞的死亡风险也较高,在医院和6个月)。总的来说,研究表明,在医院使用复苏血管内球囊闭塞主动脉增加了死亡风险。
UNASSIGNED: The most common cause of preventable death after injury is haemorrhage. Resuscitative endovascular balloon occlusion of the aorta is intended to provide earlier, temporary haemorrhage control, to facilitate transfer to an operating theatre or interventional radiology suite for definitive haemostasis.
UNASSIGNED: To compare standard care plus resuscitative endovascular balloon occlusion of the aorta versus standard care in patients with exsanguinating haemorrhage in the emergency department.
UNASSIGNED: Pragmatic, multicentre, Bayesian, group-sequential, registry-enabled, open-label, parallel-group randomised controlled trial to determine the clinical and cost-effectiveness of standard care plus resuscitative endovascular balloon occlusion of the aorta, compared to standard care alone.
UNASSIGNED: United Kingdom Major Trauma Centres.
UNASSIGNED: Trauma patients aged 16 years or older with confirmed or suspected life-threatening torso haemorrhage deemed amenable to adjunctive treatment with resuscitative endovascular balloon occlusion of the aorta.
UNASSIGNED: Participants were randomly assigned 1 : 1 to: standard care, as expected in a major trauma centre standard care plus resuscitative endovascular balloon occlusion of the aorta.
UNASSIGNED: Primary: Mortality at 90 days. Secondary: Mortality at 6 months, while in hospital, and within 24, 6 and 3 hours; need for haemorrhage control procedures, time to commencement of haemorrhage procedure, complications, length of stay (hospital and intensive care unit-free days), blood product use. Health economic: Expected United Kingdom National Health Service perspective costs, life-years and quality-adjusted life-years, modelled over a lifetime horizon.
UNASSIGNED: Case report forms, Trauma Audit and Research Network registry, NHS Digital (Hospital Episode Statistics and Office of National Statistics data).
UNASSIGNED: Ninety patients were enrolled: 46 were randomised to standard care plus resuscitative endovascular balloon occlusion of the aorta and 44 to standard care. Mortality at 90 days was higher in the standard care plus resuscitative endovascular balloon occlusion of the aorta group (54%) compared to the standard care group (42%). The odds ratio was 1.58 (95% credible interval 0.72 to 3.52). The posterior probability of an odds ratio > 1 (indicating increased odds of death with resuscitative endovascular balloon occlusion of the aorta) was 86.9%. The overall effect did not change when an enthusiastic prior was used or when the estimate was adjusted for baseline characteristics. For the secondary outcomes (3, 6 and 24 hours mortality), the posterior probability that standard care plus resuscitative endovascular balloon occlusion of the aorta was harmful was higher than for the primary outcome. Additional analyses to account for intercurrent events did not change the direction of the estimate for mortality at any time point. Death due to haemorrhage was more common in the standard care plus resuscitative endovascular balloon occlusion of the aorta group than in the standard care group. There were no serious adverse device effects. Resuscitative endovascular balloon occlusion of the aorta is less costly (probability 99%), due to the competing mortality risk but also substantially less effective in terms of lifetime quality-adjusted life-years (probability 91%).
UNASSIGNED: The size of the study reflects the relative infrequency of exsanguinating traumatic haemorrhage in the United Kingdom. There were some baseline imbalances between groups, but adjusted analyses had little effect on the estimates.
UNASSIGNED: This is the first randomised trial of the addition of resuscitative endovascular balloon occlusion of the aorta to standard care in the management of exsanguinating haemorrhage. All the analyses suggest that a strategy of standard care plus resuscitative endovascular balloon occlusion of the aorta is potentially harmful.
UNASSIGNED: The role (if any) of resuscitative endovascular balloon occlusion of the aorta in the pre-hospital setting remains unclear. Further research to clarify its potential (or not) may be required.
UNASSIGNED: This trial is registered as ISRCTN16184981.
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/199/09) and is published in full in Health Technology Assessment; Vol. 28, No. 54. See the NIHR Funding and Awards website for further award information.
Trauma (physical injury) is a major cause of death and disability. The most common cause of preventable death after injury is uncontrolled bleeding. Resuscitative endovascular balloon occlusion of the aorta is a technique whereby a small balloon is inflated in the aorta (main blood vessel) which aims to limit blood loss until an operation can be done to stop the bleeding. In this study, which is the first randomised trial in the world of this technique, we investigated whether adding resuscitative endovascular balloon occlusion of the aorta to the standard care received in a major trauma centre reduced the risk of death in trauma patients who had life-threatening uncontrolled bleeding. The study took place in 16 major trauma centres in the United Kingdom. Ninety adult trauma patients with confirmed or suspected uncontrolled bleeding took part and were randomly divided into two groups: (1) those who received standard care and (2) those who received standard care plus resuscitative endovascular balloon occlusion of the aorta. We followed participants for 6 months using routinely collected data from the National Health Service and from the Trauma Audit Research Network registry. We also contacted surviving patients at 6 months to ask about their quality of life. In the standard care group, 42% of participants died within 90 days of their injury compared to 54% of participants in the standard care plus resuscitative endovascular balloon occlusion of the aorta group. Risk of death was also higher in the standard care plus resuscitative endovascular balloon occlusion of the aorta group at all other time points (3, 6 and 24 hours, in hospital and at 6 months). Overall, the study showed that the use of resuscitative endovascular balloon occlusion of the aorta in hospital increased the risk of death.