间歇气动加压装置是否应成为重大手术预防静脉血栓栓塞事件的标准治疗方法？一项随机临床试验的方案（IMPOSTERS）。

Should intermittent pneumatic compression devices be standard therapy for the prevention of venous thromboembolic events in major surgery? Protocol for a randomised clinical trial (IMPOSTERS).

机构信息

Surgery, John Hunter Hospital, Newcastle, New South Wales, Australia

School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia.

出版信息

BMJ Open. 2024 Feb 29;14(2):e078913. doi: 10.1136/bmjopen-2023-078913.

DOI:10.1136/bmjopen-2023-078913

PMID:38423769

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10910483/

Abstract

INTRODUCTION

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%.

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

ANZCTR12622001527752.

摘要

简介

静脉血栓栓塞症（VTE）是一种公认的术后风险。目前的预防方法包括低分子肝素（LMWH）、梯度压力弹力袜（GCS）和间歇性气动压缩装置（IPCD）。澳大利亚的指南，通常被外科医生采用，建议使用 LMWH 联合 GCS 和/或 IPCD。IPCD 存在临床风险，增加护理负担，耐受性差，且为昂贵的一次性塑料用品。仅使用 LMWH 和 GCS，不使用 IPCD，可能更实用、对患者更友好且更具成本效益，并具有额外的环境效益。

方法

这是在澳大利亚新南威尔士州（NSW）五家医院进行的一项多中心、前瞻性、双臂、随机对照非劣效性试验。我们提议将 4130 名参与者按 1:1 的比例随机分配到 A 组：LMWH+GCS+IPCD（n=2065）或 B 组：LMWH+GCS（n=2065）。主要观察终点是在第 30 天电话随访（FU）时通过超声或影像学检查确定的有症状 VTE（深静脉血栓形成/肺栓塞）。解读下肢超声的放射科医生将对干预分配保持盲态。次要结局包括使用欧洲生活质量 5 级评分基线、第 30 天和第 90 天 FU 的生活质量、IPCD、GCS 和 LMWH 的依从性和不良反应，以及从患者和医院的角度出发的医疗保健费用，以及全因死亡率。该试验有 90%的效力可检测到 2%的非劣效性边际，以检测 VTE 从 4%降至 2%的降低率。