Scheer Maximilian, Schenk Grit, Taute Bettina, Richter Michael, Hlavac Michael, Gempt Jens, Krammer Matthias, Shiban Ehab, Sabel Michael, Stein Marco, Wienke Andreas, Höllig Anke, Strauss Christian, Rampp Stefan, Prell Julian
Department of Neurosurgery, University Hospital Halle, Halle, Germany.
Department of Internal Medicine, Angiology Division, University Hospital Halle, Halle, Germany.
Neurosurg Pract. 2024 Aug 28;5(4):e00109. doi: 10.1227/neuprac.0000000000000109. eCollection 2024 Dec.
Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complication in craniotomy patients. The duration of surgery has been identified as a risk factor for the development of VTE. In a pilot study, the use of intermittent pneumatic venous compression (IPC) dramatically reduced the incidence of VTE. Despite randomization, a significant difference in the duration of surgery between the groups limited the validity of this result. The study was underpowered to compensate for this problem. We now present the protocol of a multicenter trial.
All patients receive medical compression stockings and low-molecular-weight heparin from the first postoperative day. The therapy group receives IPC stockings intraoperatively. Postoperatively, all patients receive lower-extremity duplex sonography to detect/exclude DVT within the first 7 postoperative days. Contrast-enhanced chest CT is the gold standard for the detection of PE and is performed in cases of clinical suspicion of PE.
The incidence of VTE is the primary end point. The distinction between symptomatic and asymptomatic, etiologies, influence of lesion type, duration of surgery, and mortality will be evaluated as secondary end points. The pilot study showed a VTE incidence of 26% in the control group vs 7% in the treatment group. To avoid overly optimistic treatment effect assumptions, we assume VTE rates of 9% and 24% in the treatment and control groups, respectively, and thus calculated a number of 127 patients per treatment group.
If this trial shows that intraoperative IPC reduces the risk of VTE to the extent observed in our pilot study (number needed to treat: 5.24), the potential benefit to neurosurgical patients would be significant. The results would potentially influence treatment guidelines by providing the high-quality evidence needed to make robust recommendations.
静脉血栓栓塞症（VTE），包括深静脉血栓形成（DVT）和肺栓塞（PE），是开颅手术患者常见的并发症。手术时间已被确定为VTE发生的一个危险因素。在一项初步研究中，使用间歇性气动静脉压迫（IPC）显著降低了VTE的发生率。尽管进行了随机分组，但两组之间手术时间的显著差异限制了该结果的有效性。该研究的样本量不足以弥补这一问题。我们现在展示一项多中心试验的方案。
所有患者自术后第一天起接受医用压力袜和低分子量肝素治疗。治疗组在术中接受IPC压力袜治疗。术后，所有患者在术后第1天至第7天接受下肢双功超声检查以检测/排除DVT。对比增强胸部CT是检测PE的金标准，在临床怀疑PE的情况下进行。
VTE的发生率是主要终点。有症状与无症状之间的区别、病因、病变类型的影响、手术时间和死亡率将作为次要终点进行评估。初步研究显示，对照组的VTE发生率为26%，而治疗组为7%。为避免对治疗效果做出过于乐观的假设，我们假设治疗组和对照组的VTE发生率分别为9%和24%，因此计算出每组需要127名患者。
如果该试验表明术中IPC能将VTE风险降低至我们初步研究中观察到的程度（治疗所需人数：5.24），那么对神经外科患者的潜在益处将是巨大的。这些结果可能会通过提供做出有力推荐所需的高质量证据来影响治疗指南。
