探讨梯度压力弹力袜在预防低危手术患者医院相关性静脉血栓栓塞症中的作用：一项多中心整群随机对照试验（PETS 试验）。

Examining the benefit of graduated compression stockings in the prevention of hospital-associated venous thromboembolism in low-risk surgical patients: a multicentre cluster randomised controlled trial (PETS trial).

机构信息

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK.

Imperial Vascular Unit, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.

出版信息

BMJ Open. 2023 Jan 17;13(1):e069802. doi: 10.1136/bmjopen-2022-069802.

DOI:10.1136/bmjopen-2022-069802

PMID:36653057

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9853211/

Abstract

INTRODUCTION

Hospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor.

METHODS AND ANALYSIS

A multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression.

ETHICS AND DISSEMINATION

Ethical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences.

TRIAL REGISTRATION NUMBER

ISRCTN13908683.

摘要

简介

医院获得性血栓（HAT）定义为住院期间或出院后 90 天内发生的任何与静脉血栓栓塞（VTE）相关的事件，与显著的发病率、死亡率和医疗保健相关成本有关。尽管手术是 VTE 的既定危险因素，但住院时间短（<48 小时）且允许早期活动的手术与低 VTE 风险相关。许多接受短期手术且 VTE 风险低的患者接受梯度压力弹力袜（GCS）治疗。然而，对于这一人群，GCS 在 VTE 预防中的应用证据不足。

方法和分析

一项多中心、集群随机对照试验旨在确定 GCS 在预防接受短期手术且被评估为 VTE 风险低的手术患者的 VTE 方面是否优于不使用 GCS。共有 50 个站点（21472 名参与者）将被随机分配到干预组（GCS）或对照组（不使用 GCS）。将纳入接受短期手术且 VTE 风险低的成年参与者（18-59 岁）。参与者将同意在手术后 7 天和 90 天接受随访。主要结局是有症状 VTE 的发生率，即在住院期间或 90 天内发生的深静脉血栓或肺栓塞。次要结局包括医疗保健成本和生活质量的变化。主要分析将根据意向治疗原则进行，将比较 90 天内个体水平的 VTE 发生率，使用分层（多水平）逻辑回归进行测量。