PDF(Pubmed)
Abstract：
BACKGROUND: Venous thromboembolism (VTE) is a recognised postsurgical risk. Current prevention methods involve low molecular weight heparin (LMWH), graduated compression stockings (GCS), and intermittent pneumatic compression devices (IPCDs). Australian guidelines, commonly adopted by surgeons, recommend LMWH with GCS and/or IPCDs. IPCDs pose clinical risks, increase care burden, are poorly tolerated, and are costly single-use plastic items. Utilising only LMWH and GCS, without IPCDs, could be more practical, patient-friendly, and cost-effective, with added environmental benefits.
METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%.
BACKGROUND: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals.
BACKGROUND: ANZCTR12622001527752.
METHODS: This is a multicentre, prospective, two-arm randomised controlled non-inferiority trial at five New South Wales (NSW) hospitals, in Australia. We propose to randomise 4130 participants in a 1:1 ratio between arm A: LMWH+GCS+IPCDs (n=2065) or arm B: LMWH+GCS (n=2065). The primary outcome of interest is symptomatic VTE (deep vein thrombosis/pulmonary embolism) identified at the day 30 phone follow-up (FU), confirmed by ultrasound or imaging. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation. Secondary outcomes are quality of life at baseline, days 30 and 90 FU using the 5-level European Quality of Life Score, compliance and adverse events with IPCDs, GCS, and LMWH, as well as healthcare costs (from the perspective of the patient and the hospital), and all-cause mortality. The trial has 90% power to detect a 2% non-inferiority margin to detect a reduction rate of VTE from 4% to 2%.
BACKGROUND: This study has been approved by the Hunter New England Human Research Ethics Committee (2022/ETH02276) protocol V.10, 13 July 2023. Study findings will be presented at local and national conferences and in scientific research journals.
BACKGROUND: ANZCTR12622001527752.
摘要：
背景：静脉血栓栓塞（VTE）是公认的术后风险。目前的预防方法涉及低分子量肝素（LMWH），渐变压缩长袜（GCS），和间歇性气动压缩装置（IPCDs）。澳大利亚指南，通常被外科医生采用，建议使用GCS和/或IPCD的LMWH。IPCDs构成临床风险，增加护理负担，耐受性差，是昂贵的一次性塑料制品。仅使用LMWH和GCS，如果没有IPCDs，可能更实际，对病人友好,并且具有成本效益，增加环境效益。
方法：这是一个多中心，prospective,在新南威尔士州五家医院进行的双臂随机对照非劣效性试验，在澳大利亚。我们建议以1：1的比例在A组：LMWHGCSIPCD（n=2065）或B组：LMWHGCS（n=2065）之间随机分配4130名参与者。感兴趣的主要结果是在第30天电话随访（FU）时确定的症状性VTE（深静脉血栓形成/肺栓塞），通过超声或成像证实。解释下肢超声检查的放射科医生将对干预分配视而不见。次要结果是基线时的生活质量，第30天和第90天使用5级欧洲生活质量评分，IPCDs的合规性和不良事件，GCS,和LMWH,以及医疗保健费用(从患者和医院的角度来看)，和全因死亡率。该试验具有90％的能力来检测2％的非劣效性，以检测从4％到2％的VTE减少率。
背景：这项研究已获亨特新英格兰人类研究伦理委员会（2022/ETH02276）方案V.10，2023年7月13日批准。研究结果将在地方和国家会议以及科学研究期刊上发表。
背景：ANZCTR12622001527752。
方法：这是一个多中心，prospective,在新南威尔士州五家医院进行的双臂随机对照非劣效性试验，在澳大利亚。我们建议以1：1的比例在A组：LMWHGCSIPCD（n=2065）或B组：LMWHGCS（n=2065）之间随机分配4130名参与者。感兴趣的主要结果是在第30天电话随访（FU）时确定的症状性VTE（深静脉血栓形成/肺栓塞），通过超声或成像证实。解释下肢超声检查的放射科医生将对干预分配视而不见。次要结果是基线时的生活质量，第30天和第90天使用5级欧洲生活质量评分，IPCDs的合规性和不良事件，GCS,和LMWH,以及医疗保健费用(从患者和医院的角度来看)，和全因死亡率。该试验具有90％的能力来检测2％的非劣效性，以检测从4％到2％的VTE减少率。
背景：这项研究已获亨特新英格兰人类研究伦理委员会（2022/ETH02276）方案V.10，2023年7月13日批准。研究结果将在地方和国家会议以及科学研究期刊上发表。
背景：ANZCTR12622001527752。
