Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168)
| Autor: | Andrew W. Bradbury, Laura Burgess, John Norrie, Manjit S. Gohel, Alun H. Davies, Rebecca Lawton, Beverley J. Hunt, Nicky Cullum, David Epstein, Ankur Thapar, Joseph Shalhoub, Rob Horne |
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| Přispěvatelé: | National Institute for Health Research |
| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty Deep vein education Vascular medicine 030204 cardiovascular system & hematology 1117 Public Health and Health Services law.invention Postthrombotic Syndrome Anticoagulation 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Thromboembolism London medicine Clinical endpoint Humans Cumulative incidence 030212 general & internal medicine Randomized Controlled Trials as Topic Protocol (science) Venous Thrombosis Research ethics business.industry Incidence Postthrombotic Syndrome/prevention & control 1103 Clinical Sciences General Medicine medicine.disease Thrombosis medicine.anatomical_structure Physical therapy Medicine business Stockings Compression Venous Thrombosis/prevention & control 1199 Other Medical and Health Sciences Post-thrombotic syndrome |
| Zdroj: | BMJ Open, Vol 11, Iss 4 (2021) Thapar, A, Lawton, R, Burgess, L, Shalhoub, J, Bradbury, A, Cullum, N, Epstein, D, Gohel, M, Horne, R, Hunt, B J, Norrie, J & Davies, A H 2021, ' Compression hosiery to avoid post-thrombotic syndrome (CHAPS) protocol for a randomised controlled trial (ISRCTN73041168) ', BMJ Open, vol. 11, no. 4, e044285 . https://doi.org/10.1136/bmjopen-2020-044285 Digibug: Repositorio Institucional de la Universidad de Granada Universidad de Granada (UGR) Digibug. Repositorio Institucional de la Universidad de Granada instname |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2020-044285 |
| Popis: | This work was supported by the National Institute for Health Research (NIHR), Health Technology Assessment Programme, project number 17/147/47. The HTA Programme is funded by the NIHR, with contributions from the Chief Scientist Office in Scotland and National Institute for Social Care and Health Research in Wales and the Health and Social Care R&D Division, Public Health Agency in Northern Ireland. Sponsor: Imperial College London. 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. National Institute for Health Research (NIHR) 17/147/47 National Institute for Health Research (NIHR) Chief Scientist Office in Scotland National Institute for Social Care and Health Research in Wales Health and Social Care R&D Division, Public Health Agency in Northern Ireland Imperial College London |
| Databáze: | OpenAIRE |
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