Intraoperative intermittent pneumatic compression (IPC) reduces incidence of venous thromboembolism in patients undergoing craniotomy: A randomized multi-center, single-blind trial

通过开颅手术进行的神经外科手术与静脉血栓栓塞甚至危及生命的肺栓塞的风险增加有关。由于缺乏高质量的证据，目前尚无预防此类并发症的具有约束力的指南。提议小组发表的一项初步研究表明，单纯术中应用小腿间歇性气动加压（IPC）可显著降低风险。然而，主要是由于该随机对照单中心研究所依据的病例数估计中的II型错误，最终无法获得可靠的统计学显著性结果。尽管如此，由于初步研究实现了风险从26.4%降低至7.3%（需要治疗的人数为5.24），因此更大规模的多中心研究很可能证实该结果，从而提供高水平的证据，这也很可能对现有的患者管理产生直接影响，并对降低围手术期发病率和死亡率做出重大贡献。因此，我们申请了一项多中心、随机对照、单盲干预研究的资助，该研究将检查通过开颅术进行选择性神经外科手术的典型患者。在所有其他条件相同的情况下，干预组患者将在手术期间仅通过小腿袖带接受IPC。在术后第一周，对腿部静脉进行多普勒检查，以检测可能的血栓形成（包括亚临床血栓形成）。主要终点是术后第一周内深静脉血栓形成和/或栓塞的存在。关于次要终点，进一步区分：近端和远端血栓形成、症状性和无症状性血栓形成、肌肉静脉血栓形成、CVC相关血栓形成、肺栓塞和死亡。此外，可能的影响因素，如手术时间和治疗的病变类型进行了记录和调查。

Neurosurgical operations via craniotomy are associated with an increased risk of venous thromboembolism and even life-threatening pulmonary embolism. No binding guidelines exist for the prophylaxis of such complications due to lack of high-quality evidence. A pilot study published by the proposing group suggested that a pronounced risk reduction is achievable by the purely intraoperative application of intermittent pneumatic compression of the lower legs (IPC). However, mainly due to a type II error in the case number estimation on which this randomized controlled monocentric study was based, no reliable statistical significance of the results could ultimately be achieved. Since the pilot study nevertheless achieved a risk reduction from 26.4% to 7.3% (number needed to treat 5.24), the likelihood is very high that a larger, multicenter study can confirm the result and thus provide high-level evidence, which would then very likely also have a direct influence on existing patient management and could make a significant contribution to reducing perioperative morbidity and mortality. Thus, we apply for a grant enabling a multicenter, controlled randomized, single-blinded intervention study, which will examine typical patients undergoing elective neurosurgical procedures via craniotomy. All other things being equal, patients in the intervention group will receive IPC via lower leg cuffs exclusively during surgery. During the first postoperative week, a Doppler examination of the leg veins is then performed to detect possible thrombosis (including subclinical thrombosis). The primary endpoint is the presence of deep vein thrombosis and/or embolism during the first postoperative week. With regard to secondary endpoints, a further distinction is made between: Proximal and distal thromboses, symptomatic and asymptomatic thromboses, muscle vein thrombosis, CVC-associated thrombosis, pulmonary embolism, and death. Furthermore, possible influencing factors as the duration of surgery and the type of lesion treated are recorded and also investigated.