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
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 endoven...
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2024-02-01
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| author | 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 |
| author_facet | 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 |
| author_sort | John Norrie |
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| description | 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. |
| format | Article |
| id | doaj-art-e34664ba5212417aa5902c7300d21b11 |
| institution | Kabale University |
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| publishDate | 2024-02-01 |
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| spelling | doaj-art-e34664ba5212417aa5902c7300d21b112025-08-20T03:40:29ZengBMJ Publishing GroupBMJ Open2044-60552024-02-0114210.1136/bmjopen-2023-083488Evaluating 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 trialJohn Norrie0Rebecca Lawton1Joseph Shalhoub2Beverley J Hunt3Annya Stephens-Boal4Tamara Everington5Joanne Dunbar6Sarah Onida7Layla Bolton8Manjit Gohel9A H Davies10Laura Burgess11Matthew Machin12Steven Rogers13Sarah Whittley14Sandip Nandhra15Daniel Carradice16Benedict Turner17Mark S Whiteley18Carolyn Singer191 The University of Edinburgh, Edinburgh, Edinburgh, UKThe Yorkshire Quality and Safety Research Group, Bradford Institute for Health Research, Bradford, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKDepartment of Thrombosis & Haemostasis, Kings Healthcare Partners, London, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKHampshire Hospitals NHS Foundation Trust, Winchester, Hampshire, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKImperial Vascular Unit, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UKImperial Vascular Unit, St Mary’s Hospital, Imperial College Healthcare NHS Trust, London, UKCambridge Vascular Unit, Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKDivision of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKPopulation Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UKAcademic Vascular Surgical Unit, Hull York Medical School, Hull, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKThe Whiteley Clinic, London, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKIntroduction 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.https://bmjopen.bmj.com/content/14/2/e083488.full |
| spellingShingle | 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 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/14/2/e083488.full |
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