Lawton Rebecca, Heatley Francine, Beggs Andrew D, Everington Tamara, Hamady Zaed, Hunt Beverley J, Jasionowska Sara, Kyrgiou Maria, Liddle Alexander, Machin Matthew, Norrie John, Pinkney Tom, Rees Jonathan L, Saghdaoui Layla Bolton, Shalhoub Joseph, Smith Sasha, Toh Simon, Watkin Nick, Williams Linda, Davies Alun
Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, London, UK.
Department of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
BMJ Open. 2025 Jul 6;15(7):e095482. doi: 10.1136/bmjopen-2024-095482.
Venous thromboembolism (VTE) occurs when a blood clot forms in a vein. It is comprised of deep vein thrombosis (DVT) and pulmonary embolism and can be potentially life-threatening. Patients undergoing surgery are at increased risk of developing VTE within hospital admission and 90 days after hospital discharge are collectively known as hospital-acquired thrombosis (HAT). Without the use of thromboprophylaxis, the untreated risk of VTE is reported to be as high as 40-60% in those undergoing major orthopaedic procedures and around 15-40% in the general surgical population.HAT accounts for around 12 000 deaths per year in the UK. For patients undergoing surgery, there is good evidence for the use of thromboprophylaxis to prevent VTE.Thromboprophylaxis is available in both pharmacological and mechanical forms. While there is a huge body of evidence demonstrating that pharmacological thromboprophylaxis significantly reduces VTE by 30-65%, the benefit of graduated compression stockings (GCS) has been called into question. The GRACE study (Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention) aims to evaluate the adjuvant benefit of GCS in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for elective surgical patients at highest risk of VTE.
GRACE is a pragmatic, multicentre randomised trial of adults undergoing surgery who are at high risk of VTE. Participants are randomised into a 1:1 ratio to either EDPTP and compression stockings (control arm) or EDPTP (intervention arm). Following randomisation, participants will undergo surgery and be followed up centrally at 7, 21-35 and 90 days after their procedure. All participants will be offered a bilateral full lower limb duplex scan at 21-35 days post procedure to capture any asymptomatic DVT.The trial aims to randomise 8608 participants from around 50 National Health Service (NHS) and non-NHS sites in the UK over a 24-month period. The primary endpoint is any imaging-confirmed incidence of VTE within 90 days of surgery.
On 20 December 2023, GRACE received favourable ethical approval from the Wales Research Ethics Committee 3 Cardiff (23/WA/0350) and the Health Research Authority (IRAS 333539). The results of the study will be disseminated via peer-reviewed publications, presentation at national and international conferences and to study participants via electronic newsletter and social media channels.
ISRCTN11667770.
静脉血栓栓塞症（VTE）是指在静脉内形成血凝块。它由深静脉血栓形成（DVT）和肺栓塞组成，可能会危及生命。接受手术的患者在住院期间及出院后90天内发生VTE的风险增加，统称为医院获得性血栓形成（HAT）。据报道，在未进行血栓预防的情况下，接受大型骨科手术的患者VTE未治疗风险高达40%-60%，普通外科患者约为15%-40%。在英国，HAT每年导致约12000人死亡。对于接受手术的患者，有充分证据支持使用血栓预防措施来预防VTE。
血栓预防措施有药物和机械两种形式。虽然有大量证据表明药物性血栓预防可使VTE显著降低30%-65%，但分级压力袜（GCS）的益处受到了质疑。GRACE研究（分级压力袜作为延长药物性血栓预防的辅助措施预防静脉血栓栓塞症）旨在评估GCS在延长药物性血栓预防（EDPTP）基础上对VTE风险最高的择期手术患者的辅助益处。
GRACE是一项针对VTE高风险成年手术患者的实用、多中心随机试验。参与者按1:1比例随机分为EDPTP加压力袜组（对照组）或EDPTP组（干预组）。随机分组后，参与者将接受手术，并在术后7天、21-35天和90天进行集中随访。所有参与者将在术后21-35天接受双侧全下肢双功扫描，以发现任何无症状DVT。
该试验旨在在24个月内从英国约50个国民健康服务（NHS）和非NHS机构随机招募8608名参与者。主要终点是术后90天内任何影像学确诊的VTE发生率。
2023年12月20日，GRACE获得了威尔士研究伦理委员会3卡迪夫（23/WA/0350）和健康研究管理局（IRAS 333539）的有利伦理批准。研究结果将通过同行评审出版物、在国内和国际会议上发表以及通过电子通讯和社交媒体渠道向研究参与者传播。
ISRCTN11667770。
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