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在开放腹腔大动脉动脉瘤修复过程中激活凝血时间引导肝素化 (ACTION-1): 一个随机,多中心,单盲,优越性试验
Vincent Jongkind1, Thomas A H Steunenberg2, Liliane C Roosendaal2
1Department of Vascular Surgery, Amsterdam University Medical Centres, location Vrije Universiteit, Amsterdam, the Netherlands; Department of Vascular Surgery, Dijklander Hospital, Hoorn, the Netherlands; Amsterdam Cardiovascular Sciences, Atherosclerosis and Aortic Disease, Amsterdam, the Netherlands.
概括
激活凝血时间 (ACT) 引导的肝化并没有改善开放腹腔大动脉瘤 (AAA) 修复的结果和增加出血风险. 单次肝素剂量被证明更安全,同样有效地预防血栓栓塞并发症 (TECs).
科学领域:
- 血管外科 血管外科
- 麻醉学 麻醉学
- 血栓形成和血液静止.
背景情况:
- 关于最佳静脉未分离氨酸剂量和激活凝血时间 (ACT) 监测在开放腹腔大动脉瘤 (AAA) 修复期间预防血栓栓塞并发症 (TECs) 的实用性,存在不确定性.
- 目前的做法各不相同,因此需要明确比较标准化肝素剂量与ACT指导策略.
研究的目的:
- 在接受开放AAA修复的患者中,比较ACT导向肝素化与标准单剂肝素剂的疗效和安全性.
- 评估对预防TEC和全因死亡的影响,以及出血并发症的发生率.
主要方法:
- 一个多中心,随机控制,单盲优越性试验,涉及294名接受选择性开放AAA修复的患者.
- 患者被随机分配到ACT引导的肝激素化 (100IU/kg,目标200秒) 或接受单次5000IU肝激素注射剂的对照组.
- 主要结局是30天后TEC和所有原因死亡的综合发病率;安全结局是出血并发症.
主要成果:
- 由于徒劳,审判被提前停止. 在ACT指导组 (22.8%) 和对照组 (25.5%) 的初级结果中没有发现显著差异.
- 在ACT引导的肝激活组中,出血并发症 (绝对差异9.2%) 和死亡 (绝对差异7.9%) 的发生率较高.
- 两组之间的血栓栓塞并发症 (TEC) 发生率没有差异.
结论:
- 在200秒的目标时,以ACT监测为指导的肝化并没有降低开放AAA修复中的初级疗效结果.
- 这一策略显著增加了术前出血和死亡的风险,与单一的5000 IU肝素玻尿酸相比.
- 单个肝素玻尿酸似乎是一个更安全和同样有效的方法来预防TECs在这个患者群体.
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