Cardiovascular Division, The Rayne Institute BHF Centre of Research Excellence, King's College London, St. Thomas' Hospital, London, UK.
Warwick Clinical Trials Unit and Heart of England NHS Foundation Trust, Warwick Medical School, University of Warwick, Coventry, UK.
Resuscitation. 2017 Jun;115:185-191. doi: 10.1016/j.resuscitation.2017.01.020. Epub 2017 Feb 4.
Wide variation exists in inter-hospital survival from out-of-hospital cardiac arrest (OHCA). Regionalisation of care into cardiac arrest centres (CAC) may improve this. We report a pilot randomised trial of expedited transfer to a CAC following OHCA without ST-elevation. The objective was to assess the feasibility of performing a large-scale randomised controlled trial.
Adult witnessed ventricular fibrillation OHCA of presumed cardiac cause were randomised 1:1 to either: (1) treatment: comprising expedited transfer to a CAC for goal-directed therapy including access to immediate reperfusion, or (2) control: comprising current standard of care involving delivery to the geographically closest hospital. The feasibility of randomisation, protocol adherence and data collection of the primary (30-day all-cause mortality) and secondary (cerebral performance category (CPC)) and in-hospital major cardiovascular and cerebrovascular events (MACCE) clinical outcome measures were assessed.
Between November 2014 and April 2016, 118 cases were screened, of which 63 patients (53%) met eligibility criteria and 40 of the 63 patients (63%) were randomised. There were no protocol deviations in the treatment arm. Data collection of primary and secondary outcomes was achieved in 83%. There was no difference in baseline characteristics between the groups: 30-day mortality (Intervention 9/18, 50% vs. Control 6/15, 40%; P=0.73), CPC 1/2 (Intervention: 9/18, 50% vs. Control 7/14, 50%; P>0.99) or MACCE (Intervention: 9/18, 50% vs. Control 6/15, 40%; P=0.73).
These findings support the feasibility and acceptability of conducting a large-scale randomised controlled trial of expedited transfer to CAC following OHCA to address a remaining uncertainty in post-arrest care.
院外心脏骤停(OHCA)患者的院内存活率存在很大差异。将医疗服务区域化,建立心脏骤停中心(CAC),可能会改善这一状况。我们报告了一项关于无 ST 段抬高的 OHCA 后,将患者迅速转至 CAC 的试点随机试验。本研究的目的是评估开展大规模随机对照试验的可行性。
本研究纳入了经证实由心源性原因引起的成人目击性室颤 OHCA 患者,按照 1:1 的比例随机分配至以下两组:(1)治疗组:接受迅速转至 CAC 的治疗,包括进行目标导向治疗,以及可立即进行再灌注治疗;(2)对照组:接受当前地理上最近的医院提供的标准治疗。本研究评估了随机分组、方案依从性和主要结局(30 天全因死亡率)、次要结局(脑功能预后分类(CPC))以及院内主要心脑血管不良事件(MACCE)临床结局指标数据收集的可行性。
2014 年 11 月至 2016 年 4 月期间,共筛选了 118 例患者,其中 63 例(53%)符合纳入标准,63 例患者中有 40 例(63%)被随机分组。治疗组无方案偏离。主要和次要结局数据的收集率为 83%。两组间的基线特征无差异:30 天死亡率(干预组 9/18,50% vs. 对照组 6/15,40%;P=0.73)、CPC1/2(干预组:9/18,50% vs. 对照组:7/14,50%;P>0.99)或 MACCE(干预组:9/18,50% vs. 对照组:6/15,40%;P=0.73)。
这些结果支持对 OHCA 后迅速转至 CAC 进行大规模随机对照试验的可行性和可接受性,以解决复苏后治疗中尚存的不确定性。