THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment: a multi-centre, assessor blind, randomised controlled trial (THRIVE trial)

Matthew Machin, Sarah Whittley, John Norrie, Laura Burgess, Beverley J. Hunt, Layla Bolton Saghdaoui, Joseph Shalhoub, Tamara Everington, Manjit Gohel, Mark Whiteley, Steven Rogers, Sarah Onida, Benedict Turner, Sandip Nandhra, Rebecca Lawton, Annya Stephens-Boal, Carolyn Singer, Joanne Dunbar, Alun Huw Davies, Daniel Carradice
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Abstract

Introduction Endovenous therapy is the first-choice management for symptomatic varicose veins in NICE guidelines, with 56-70,000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), and endothermal heat-induced thrombosis (EHIT), are known complications of endovenous therapy, occurring at a rate of up to 3.4%. In an attempt to reduce VTE, 73% of UK practitioners administer pharmacological thromboprophylaxis. However, no high-quality evidence to support this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE, however, further evidence is needed. The aims of this study are to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. Methods and analysis A multi-centre, assessor-blind, randomised controlled trial (RCT). We aim to recruit 6660 participants undergoing superficial endovenous interventions under local anaesthesia. Forty sites across the UK, both NHS and private, will be included. Participants will be randomised to either intervention (a single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The ultrasound duplex scan will be conducted locally by blinded assessors. Participants will also be contacted remotely for follow-up at 7-days and 90-days post-procedure. The primary outcome is imaging confirmed lower limb DVT with or without symptoms, or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance (ANOVA), adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression.
在接受浅表内瘘治疗的患者中预防颅内血栓形成:一项多中心、评估者盲法随机对照试验(THRIVE 试验)
导言:根据 NICE 指南,静脉腔内治疗是治疗症状性静脉曲张的首选方法,英国每年进行 56-70,000 例手术。静脉血栓栓塞(VTE),包括深静脉血栓(DVT)和肺栓塞(PE),以及内热诱发血栓(EHIT),是静脉腔内治疗的已知并发症,发生率高达 3.4%。为了减少 VTE 的发生,英国 73% 的医生都会采取药物血栓预防措施。然而,没有高质量的证据支持这种做法。药理血栓预防在预防 VTE 方面可能具有临床和成本效益,但还需要进一步的证据。本研究旨在确定在进行静脉腔内治疗时:单剂量或疗程的药物血栓预防是否会改变 VTE 风险;药物血栓预防是否与出血事件发生率增加有关;药物预防是否具有成本效益。我们的目标是招募 6660 名参与者,在局部麻醉下接受浅表静脉腔内介入治疗。英国国家医疗服务系统(NHS)和私立医疗机构的40家医疗机构将参与其中。参与者将被随机分为干预组(单剂量或延长疗程的药物血栓预防加压疗法)或对照组(单独加压疗法)。参与者将在手术后 21-28 天接受下肢静脉双联超声波扫描,以确定无症状的深静脉血栓。超声双相扫描将由盲人评估员在当地进行。参与者还将在术后 7 天和 90 天接受远程随访。主要结果是经影像学确诊的下肢深静脉血栓(有或无症状),或在治疗后90天内出现有症状的PE。主要分析将遵循意向治疗原则,使用重复测量方差分析(ANOVA)比较 90 天后的 VTE 发生率,并使用混合效应逻辑回归调整任何预先指定的强预后基线协变量。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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