Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)
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
Affiliations
John Norrie
Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
Rebecca Lawton
2University of Leeds, UK
Nicky Cullum
Division of Nursing, Midwifery & Social Work, School of Health Sciences, Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UK
Joseph Shalhoub
Imperial College Healthcare NHS Trust, London, UK
Beverley J Hunt
Department of Thrombosis & Haemostasis, Kings Healthcare Partners, London, UK
Robert Horne
Centre for Behavioural Medicine, UCL School of Pharmacy - UCL, Asthma UK Centre for Applied Research, London, UK
Andrew Bradbury
Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK
David Epstein
Faculty of Economic and Business Sciences, University of Granada, Granada, Andalucía, Spain
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
Ankur Thapar
Academic Section of Vascular Surgery, Imperial College London, London, UK
Laura Burgess
Section of Vascular Surgery, Department of Surgery and Cancer, Charing Cross Hospital, Imperial College London, London, UK
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.
