Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)
Introduction Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.Methods and analysis Pragmatic, UK multicentre randomised trial in...
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| Format: | Article |
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BMJ Publishing Group
2021-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/11/4/e044285.full |
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| author | John Norrie Rebecca Lawton Nicky Cullum Joseph Shalhoub Beverley J Hunt Robert Horne Andrew Bradbury David Epstein Manjit Gohel A H Davies Ankur Thapar Laura Burgess |
| author_facet | John Norrie Rebecca Lawton Nicky Cullum Joseph Shalhoub Beverley J Hunt Robert Horne Andrew Bradbury David Epstein Manjit Gohel A H Davies Ankur Thapar Laura Burgess |
| author_sort | John Norrie |
| collection | DOAJ |
| description | Introduction Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.Methods and analysis Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.Ethics and dissemination UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.Trial registration number ISRCTN registration number 73041168. |
| format | Article |
| id | doaj-art-c311859f5f2d4ca4a7cea0edb90ac8bb |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-c311859f5f2d4ca4a7cea0edb90ac8bb2024-11-18T04:55:07ZengBMJ Publishing GroupBMJ Open2044-60552021-04-0111410.1136/bmjopen-2020-044285Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)John Norrie0Rebecca Lawton1Nicky Cullum2Joseph Shalhoub3Beverley J Hunt4Robert Horne5Andrew Bradbury6David Epstein7Manjit Gohel8A H Davies9Ankur Thapar10Laura Burgess11Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK2University of Leeds, UKDivision of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UKImperial College Healthcare NHS Trust, London, UKDepartment of Thrombosis & Haemostasis, Kings Healthcare Partners, London, UKCentre for Behavioural Medicine, UCL School of Pharmacy - UCL, Asthma UK Centre for Applied Research, London, UKInstitute of Cardiovascular Sciences, University of Birmingham, Birmingham, UKFaculty of Economic and Business Sciences, University of Granada, Granada, Andalucía, SpainCambridge 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, UKAcademic Section of Vascular Surgery, Imperial College London, London, UKSection of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UKIntroduction Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.Methods and analysis Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.Ethics and dissemination UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.Trial registration number ISRCTN registration number 73041168.https://bmjopen.bmj.com/content/11/4/e044285.full |
| spellingShingle | John Norrie Rebecca Lawton Nicky Cullum Joseph Shalhoub Beverley J Hunt Robert Horne Andrew Bradbury David Epstein Manjit Gohel A H Davies Ankur Thapar Laura Burgess Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168) BMJ Open |
| title | Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168) |
| title_full | Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168) |
| title_fullStr | Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168) |
| title_full_unstemmed | Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168) |
| title_short | Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168) |
| title_sort | compression hosiery to avoid post thrombotic syndrome chaps protocol for a randomised controlled trial isrctn73041168 |
| url | https://bmjopen.bmj.com/content/11/4/e044285.full |
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