Intraoperative Intermittent Pneumatic Compression Reduces Incidence of Venous Thromboembolism in Patients Undergoing Craniotomy: Study Protocol of a Randomized Multicenter, Single-Blind Trial

被引：0

作者：

Scheer, Maximilian ^{[1
]}

Schenk, Grit ^{[1
]}

Taute, Bettina ^{[2
]}

Richter, Michael ^{[3
]}

Hlavac, Michael ^{[4
]}

Gempt, Jens ^{[5
]}

Krammer, Matthias ^{[6
]}

Shiban, Ehab ^{[7
]}

Sabel, Michael ^{[8
]}

Stein, Marco ^{[9
]}

Wienke, Andreas ^{[10
]}

Hoellig, Anke ^{[12
]}

Strauss, Christian ^{[1
]}

Rampp, Stefan ^{[1
,11
]}

Prell, Julian ^{[1
]}

机构：

[1] Univ Hosp Halle, Dept Neurosurg, Halle, Germany

[2] Univ Hosp Halle, Dept Internal Med, Angiol Div, Halle, Germany

[3] Univ Halle, Coordinat Ctr Clin Trials, Halle, Germany

[4] Univ Ulm, Dept Neurosurg, Bezirksklinikum Gunzburg, Ulm, Germany

[5] Univ Hopsital Hamburg Eppendorf, Dept Neurosurg, Hamburg, Germany

[6] Klinikum Bogenhausen, Dept Neurosurg, Munich, Germany

[7] Carl Thiem Klinikum Cottbus, Dept Neurosurg, Cottbus, Germany

[8] Univ Hosp Dusseldorf, Dept Neurosurg, Dusseldorf, Germany

[9] Univ Hosp Giessen, Dept Neurosurg, Giessen, Germany

[10] Univ Halle Wittenberg, Inst Med Epidemiol Biostat & Informat, Halle, Germany

[11] Univ Hosp Erlangen, Dept Neurosurg, Dept Neuroradiol, Erlangen, Germany

[12] Univ Hosp Aachen, Dept Neurosurg, Aachen, Germany

来源：

NEUROSURGERY PRACTICE | 2024年 / 5卷 / 04期

关键词：

Deep vein thrombosis; Pulmonary embolism; Neuro-oncology; THROMBOSIS; PREVENTION; RISK; SURGERY;

D O I：

10.1227/neuprac.0000000000000109

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

BACKGROUND AND OBJECTIVE: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. METHODS: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. EXPECTED OUTCOMES: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. DISCUSSION: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.

引用

页数：7

共 25 条

[11] Venous thromboembolism: deep venous thrombosis and pulmonary embolism in a neurosurgical population Clinical article [J].