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

点击翻译按钮获取中文摘要

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.