Roosendaal Liliane C, Hoebink Max, Wiersema Arno M, Blankensteijn Jan D, Jongkind Vincent
Department of Vascular Surgery, Dijklander Ziekenhuis, Maelsonstraat 3, 1624 NP, Hoorn, The Netherlands.
Department of Vascular Surgery, Amsterdam UMC, Location VUmc, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Pilot Feasibility Stud. 2024 May 8;10(1):73. doi: 10.1186/s40814-024-01500-9.
Arterial thrombo-embolic complications (TEC) are still common during and after non-cardiac arterial procedures (NCAP). While unfractionated heparin has been used during NCAP for more than 70 years to prevent TEC, there is no consensus regarding the optimal dosing strategy. The aim of this pilot study was to test the effectiveness and feasibility of an activated clotting time (ACT)-guided heparinization protocol during open abdominal aortic aneurysm (AAA) surgery, in anticipation of a randomized controlled trial (RCT) investigating if ACT-guided heparinization leads to better clinical outcomes compared to a single bolus of 5000 IU of heparin.
A prospective multicentre pilot study was performed. All patients undergoing elective open repair for an AAA (distal of the superior mesenteric artery) between March 2017 and January 2020 were included. Two heparin dosage protocols were compared: ACT-guided heparinization with an initial dose of 100 IU/kg versus a bolus of 5000 IU. The primary outcome was the effectiveness and feasibility of an ACT-guided heparinization protocol with an initial heparin dose of 100 IU/kg during open AAA surgery. Bleeding complications, TEC, and mortality were investigated for safety purposes.
A total of 50 patients were included in the current study. Eighteen patients received a single dose of 5000 IU of heparin and 32 patients received 100 IU/kg of heparin with additional doses based on the ACT. All patients who received the 100 IU/kg dosing protocol reached the target ACT of > 200 s. In the 5000 IU group, TEC occurred in three patients (17%), versus three patients (9.4%) in the 100 IU/kg group. Bleeding complications were found in six patients (33%) in the 5000 IU group and in 9 patients (28%) in the 100 IU/kg group. No mortality occurred in either group.
This pilot study demonstrated that ACT-guided heparinization with an initial dose of 100 IU/kg appears to be feasible and leads to adequate anticoagulation levels. Further randomized studies seem feasible and warranted to determine whether ACT-guided heparinization results in better outcomes after open AAA repair.
在非心脏动脉手术（NCAP）期间及术后，动脉血栓栓塞并发症（TEC）仍然很常见。虽然普通肝素在NCAP中已使用70多年来预防TEC，但关于最佳给药策略尚无共识。这项前瞻性研究的目的是测试在开放性腹主动脉瘤（AAA）手术期间活化凝血时间（ACT）引导的肝素化方案的有效性和可行性，以期开展一项随机对照试验（RCT），研究ACT引导的肝素化与单次静脉注射5000IU肝素相比是否能带来更好的临床结果。
进行了一项前瞻性多中心试点研究。纳入2017年3月至2020年1月期间所有接受择期开放性修复（肠系膜上动脉远端）AAA的患者。比较了两种肝素给药方案：初始剂量为100IU/kg的ACT引导肝素化与单次静脉注射5000IU。主要结局是在开放性AAA手术期间初始肝素剂量为100IU/kg的ACT引导肝素化方案的有效性和可行性。出于安全目的，对出血并发症、TEC和死亡率进行了调查。
本研究共纳入50例患者。18例患者接受单次5000IU肝素治疗，32例患者接受100IU/kg肝素治疗，并根据ACT调整追加剂量。所有接受100IU/kg给药方案的患者均达到目标ACT>200秒。在5000IU组中，3例患者（17%）发生TEC，而在100IU/kg组中为3例患者（9.4%）。5000IU组6例患者（33%）出现出血并发症，100IU/kg组9例患者（28%）出现出血并发症。两组均未发生死亡。
这项试点研究表明，初始剂量为100IU/kg的ACT引导肝素化似乎是可行的，并能达到足够的抗凝水平。进一步的随机研究似乎是可行的，并且有必要确定ACT引导的肝素化在开放性AAA修复后是否能带来更好的结果。
