Bachler Mirjam, Hell Tobias, Bösch Johannes, Treml Benedikt, Schenk Bettina, Treichl Benjamin, Friesenecker Barbara, Lorenz Ingo, Stengg Daniel, Hruby Stefan, Wallner Bernd, Oswald Elgar, Ströhle Mathias, Niederwanger Christian, Irsara Christian, Fries Dietmar
Institute for Sports Medicine, Alpine Medicine and Health Tourism, UMIT-University for Health Sciences, Medical Informatics and Technology, 6060 Hall in Tirol, Austria.
Department of Mathematics, Faculty of Mathematics, Computer Science and Physics, University of Innsbruck, 6020 Innsbruck, Austria.
J Clin Med. 2020 Mar 31;9(4):963. doi: 10.3390/jcm9040963.
The current study aims to evaluate whether prophylactic anticoagulation using argatroban or an increased dose of unfractionated heparin (UFH) is effective in achieving the targeted activated partial thromboplastin time (aPTT) of more than 45 s in critically ill heparin-resistant (HR) patients. Patients were randomized either to continue receiving an increased dose of UFH, or to be treated with argatroban. The endpoints were defined as achieving an aPTT target of more than 45 s at 7 h and 24 h. This clinical trial was registered on clinicaltrials.gov (NCT01734252) and on EudraCT (2012-000487-23). A total of 42 patients, 20 patients in the heparin and 22 in the argatroban group, were included. Of the patients with continued heparin treatment 55% achieved the target aPTT at 7 h, while only 40% of this group maintained the target aPTT after 24 h. Of the argatroban group 59% reached the target aPTT at 7 h, while at 24 h 86% of these patients maintained the targeted aPTT. Treatment success at 7 h did not differ between the groups ( = 0.1000), whereas at 24 h argatroban showed significantly greater efficacy ( = 0.0021) than did heparin. Argatroban also worked better in maintaining adequate anticoagulation in the further course of the study. There was no significant difference in the occurrence of bleeding or thromboembolic complications between the treatment groups. In the case of heparin-resistant critically ill patients, argatroban showed greater efficacy than did an increased dose of heparin in achieving adequate anticoagulation at 24 h and in maintaining the targeted aPTT goal throughout the treatment phase.
本研究旨在评估使用阿加曲班或增加普通肝素（UFH）剂量进行预防性抗凝，对于重症肝素抵抗（HR）患者实现活化部分凝血活酶时间（aPTT）超过45秒的目标是否有效。患者被随机分为继续接受增加剂量的UFH组或接受阿加曲班治疗组。终点定义为在7小时和24小时时达到aPTT目标值超过45秒。该临床试验已在clinicaltrials.gov（NCT01734252）和EudraCT（2012 - 000487 - 23）上注册。共纳入42例患者，肝素组20例，阿加曲班组22例。继续接受肝素治疗的患者中，55%在7小时时达到目标aPTT，而该组仅40%在24小时后维持目标aPTT。阿加曲班组中，59%在7小时时达到目标aPTT，而在24小时时，这些患者中有86%维持了目标aPTT。两组在7小时时的治疗成功率无差异（P = 0.1000），而在24小时时，阿加曲班的疗效显著优于肝素（P = 0.0021）。在研究的后续过程中，阿加曲班在维持适当抗凝方面也表现更好。治疗组之间出血或血栓栓塞并发症的发生率无显著差异。对于肝素抵抗的重症患者，在24小时达到充分抗凝以及在整个治疗阶段维持目标aPTT方面，阿加曲班比增加剂量的肝素显示出更大的疗效。
