Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular. A RCT will evaluate if ACT-guided heparinization results in less TEC than the current standard: a single bolus of 5000 IU of heparin and no measurements at all. A goal ACT of 200–220 s should be reached during ACT-guided heparinization and this should decrease (mortality caused by) TEC, while not increasing major bleeding complications. This RCT will be executed during open abdominal aortic aneurysm (AAA) surgery, as this is a standardized procedure throughout Europe. Seven hundred fifty patients, who will undergo open AAA repair of an aneurysm originating below the superior mesenteric artery, will be randomised in 2 treatment arms: 5000 IU of heparin and no ACT measurements and no additional doses of heparin, or a protocol of 100 IU/kg bolus of heparin and ACT measurements after 5 min, and then every 30 min. The goal ACT is 200–220 s. If the ACT after 5 min is < 180 s, 60 IU/kg will be administered; if the ACT is between 180 and 200 s, 30 IU/kg. If the ACT is > 220 s, no extra heparin is given, and the ACT is measured after 30 min and then the same protocol is applied. The expected incidence for the combined endpoint of TEC and mortality is 19% for the 5000 IU group and 11% for the ACT-guided group. The ACTION-1 trial is an international RCT during open AAA surgery, designed to show superiority of ACT-guided heparinization compared to the current standard of a single bolus of 5000 IU of heparin. A significant reduction in TEC and mortality, without more major bleeding complications, must be proven with a relevant economic benefit. NTR NL8421 ClinicalTrials.gov NCT04061798 . Registered on 20 August 2019 EudraCT 2018-003393-27

中文翻译：

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ACTION-1：开放腹主动脉瘤修复期间 ACT 引导肝素化的随机对照试验研究方案

肝素在全球所有非心脏动脉手术 (NCAP) 中用于减少血栓栓塞并发症 (TEC) 已有 70 年历史。但肝素也会增加失血量，从而可能对患者造成伤害。肝素对个体患者具有不可预测的作用。活化凝血时间（ACT）可以衡量肝素的作用。目前，与心脏介入（开放式和血管内介入）期间相反，NCAP 期间并未测量该 ACT 作为护理标准。RCT 将评估 ACT 引导的肝素化导致的 TEC 是否低于当前标准：单次推注 5000 IU 肝素且根本不进行任何测量。在 ACT 引导的肝素化过程中应达到 200-220 秒的目标 ACT，这应减少 TEC（由 TEC 引起的死亡率），同时不会增加主要出血并发症。该随机对照试验将在开放性腹主动脉瘤 (AAA) 手术期间执行，因为这是整个欧洲的标准化手术。750 名患者将接受肠系膜上动脉以下动脉瘤的开放式 AAA 修复术，他们将被随机分为 2 个治疗组：5000 IU 肝素，无 ACT 测量且无额外剂量的肝素，或 100 IU 方案/kg 肝素推注，5 分钟后测量 ACT，然后每 30 分钟测量一次。目标 ACT 是 200-220 秒。如果5分钟后ACT<180秒，则给予60IU/kg；如果 ACT 在 180 至 200 秒之间，则为 30 IU/kg。如果ACT > 220 s，则不给予额外的肝素，并在30分钟后测量ACT，然后应用相同的方案。5000 IU 组的 TEC 和死亡率组合终点的预期发生率为 19%，ACT 指导组为 11%。ACTION-1 试验是开放性 AAA 手术期间的一项国际随机对照试验，旨在显示 ACT 引导的肝素化相对于目前单次推注 5000 IU 肝素的标准的优越性。TEC 和死亡率的显着降低，且没有更多严重出血并发症，必须证明具有相关的经济效益。NTR NL8421 ClinicalTrials.gov NCT04061798。2019 年 8 月 20 日注册 EudraCT 2018-003393-27