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.

Feb 19, 2024

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

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.
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.
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.
ISRCTN18501431.

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.

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ABOUT THE EXPERTS

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

Matthew Machin

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.

Sarah Whittley

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

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.

Laura Burgess

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

Beverley J Hunt

Thrombosis and Haemophilia Centre, Guy’s and St Thomas’ Foundation Trust, London, UK.

Layla Bolton

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

Joseph Shalhoub

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.

Tamara Everington

Hampshire Hospitals NHS Foundation Trust, Winchester, Hampshire, UK.

Manjit Gohel

Cambridge Vascular Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.

Mark S Whiteley

The Whiteley Clinic, 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.

Manchester Academic Vascular Research and Innovation Centre (MAVRIC), Manchester University NHS Foundation Trust, Manchester, UK.

Sarah Onida

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.

Benedict Turner

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.

Rebecca Lawton

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

Annya Stephens-Boal

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

Carolyn Singer

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

Joanne Dunbar

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

Daniel Carradice

Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.

A H Davies

Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK a.h.davies@imperial.ac.uk.

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