Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK: a multi-centre, assessor-blind, randomised controlled trial—THRIVE trial
John Norrie,
Rebecca Lawton,
Joseph Shalhoub,
Beverley J Hunt,
Annya Stephens-Boal,
Tamara Everington,
Joanne Dunbar,
Sarah Onida,
Layla Bolton,
Manjit Gohel,
A H Davies,
Laura Burgess,
Matthew Machin,
Steven Rogers,
Sarah Whittley,
Sandip Nandhra,
Daniel Carradice,
Benedict Turner,
Mark S Whiteley,
Carolyn Singer
Affiliations
John Norrie
Edinburgh Clinical Trials Unit, University of Edinburgh, Level 2, NINE Edinburgh BioQuarter, The University of Edinburgh, Usher Institute of Population Health Sciences and Informatics, Edinburgh, UK
Rebecca Lawton
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Joseph Shalhoub
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Beverley J Hunt
Thrombosis and Haemophilia Centre, Kings Healthcare Partners, London, UK
Annya Stephens-Boal
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Tamara Everington
Hampshire Hospitals NHS Foundation Trust, Winchester, Hampshire, UK
Joanne Dunbar
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Sarah Onida
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Layla Bolton
Imperial Vascular Unit, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UK
Manjit Gohel
Cambridge Vascular Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK
A H Davies
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Laura Burgess
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Matthew Machin
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Steven Rogers
Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
Sarah Whittley
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Sandip Nandhra
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK
Daniel Carradice
Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK
Benedict Turner
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
Mark S Whiteley
The Whiteley Clinic, London, UK
Carolyn Singer
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
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), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims 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) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (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 duplex scan will be conducted locally by blinded assessors. Participants will 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, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression.Ethics and dissemination Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences.Trial registration number ISRCTN18501431.
