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

通过开颅手术进行神经外科手术会增加静脉血栓栓塞症，甚至危及生命的肺栓塞的风险。由于缺乏高质量的证据，对于此类并发症的预防没有具有约束力的指南。建议小组发表的一项初步研究表明，单纯在手术中应用间歇性小腿气动加压(IPC)可以显著降低风险。然而，主要是由于这项随机对照单中心研究所基于的病例数估计中存在II型错误，最终无法实现可靠的统计意义。尽管如此，先导研究还是将风险从26.4%降低到7.3%(需要治疗5.24人)，因此，一项更大规模的多中心研究很有可能证实这一结果，从而提供高水平的证据，这很可能也将对现有的患者管理产生直接影响，并可能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、对照、随机、单盲干预研究的拨款，该研究将检查通过开颅手术进行选择性神经外科手术的典型患者。在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口接受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出现深静脉血栓和/或血栓。对于次级终点，进一步区分：近端和远端血栓、有症状和无症状血栓、肌肉静脉血栓、下腔静脉相关血栓、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也被记录和调查。

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.