Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)

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Title: Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)
Authors: Thapar, A
Lawton, R
Burgess, L
Shalhoub, J
Bradbury, A
Cullum, N
Epstein, D
Gohel, M
Horne, R
Hunt, B
Norrie, J
Davies, A
Item Type: Journal Article
Abstract: 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.
Issue Date: 12-Apr-2021
Date of Acceptance: 9-Mar-2021
DOI: 10.1136/bmjopen-2020-044285
ISSN: 2044-6055
Publisher: BMJ Journals
Journal / Book Title: BMJ Open
Volume: 11
Issue: 4
Copyright Statement: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:
Sponsor/Funder: National Institute for Health Research
Funder's Grant Number: 17/147/47
Keywords: 1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status: Published
Article Number: e04428
Online Publication Date: 2021-04-12
Appears in Collections:Department of Surgery and Cancer
Faculty of Medicine

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