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Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol)
INTRODUCTION: About 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take ho...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7759964/ https://www.ncbi.nlm.nih.gov/pubmed/33361166 http://dx.doi.org/10.1136/bmjopen-2020-042101 |
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author | Aijaz, Saba Sheikh, Sana Pathan, Asad |
author_facet | Aijaz, Saba Sheikh, Sana Pathan, Asad |
author_sort | Aijaz, Saba |
collection | PubMed |
description | INTRODUCTION: About 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes. METHODS AND ANALYSIS: It will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ(2) test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant. ETHICS AND DISSEMINATION: Ethical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications. TRIAL REGISTRATION NUMBER: NCT04380883; Pre-results. |
format | Online Article Text |
id | pubmed-7759964 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-77599642021-01-05 Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol) Aijaz, Saba Sheikh, Sana Pathan, Asad BMJ Open Cardiovascular Medicine INTRODUCTION: About 2%–30% of cardiac catheterisation procedures get complicated by radial artery occlusion (RAO). Ensuring patent haemostasis appears to be an important factor in reducing RAO. Currently employed method is a radial compression device (RCD) such as transradial band (TRB) that take hours to achieve haemostasis and cause discomfort to the patients. Haemostatic pads offer an alternative to RCD with reduced time to achieve haemostasis. Our trial aims to determine the non-inferiority of the catecholamine chitosan-based pad (InnoSEAL haemostatic pad) used in conjunction with TRB (InnoSEAL +TRB) when compared with the TRB alone in reducing composite adverse access site outcomes. METHODS AND ANALYSIS: It will be an open-label, parallel, randomised controlled trial on 714 adult patients (325 in each arm) undergoing coronary procedure using transradial approach at a cardiac health facility over 7 months duration. InnoSEAL patch along with TRB will be used to control bleeding in intervention arm and TRB alone in control arm, which is the standard practice. Study primary outcomes include RAO and haematoma; secondary outcomes are compression time, patient discomfort, time to discharge and ease of use of the intervention technique by the healthcare staff. χ(2) test will be used to compare the categorical outcomes between two arms and student’s t-test for continuous outcomes. A p value of <0.05 will be considered significant. ETHICS AND DISSEMINATION: Ethical approval for the study has been obtained from the Institutional Review Board of Tabba Heart Institute number IORG0007863. Findings will be disseminated through seminars and scientific publications. TRIAL REGISTRATION NUMBER: NCT04380883; Pre-results. BMJ Publishing Group 2020-12-23 /pmc/articles/PMC7759964/ /pubmed/33361166 http://dx.doi.org/10.1136/bmjopen-2020-042101 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Cardiovascular Medicine Aijaz, Saba Sheikh, Sana Pathan, Asad Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol) |
title | Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol) |
title_full | Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol) |
title_fullStr | Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol) |
title_full_unstemmed | Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol) |
title_short | Combination of InnoSEAL plus TR band compared with TR band alone for radial artery outcomes in patients undergoing transradial coronary intervention (InnoSEAL-II): an open-label randomised controlled trial (protocol) |
title_sort | combination of innoseal plus tr band compared with tr band alone for radial artery outcomes in patients undergoing transradial coronary intervention (innoseal-ii): an open-label randomised controlled trial (protocol) |
topic | Cardiovascular Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7759964/ https://www.ncbi.nlm.nih.gov/pubmed/33361166 http://dx.doi.org/10.1136/bmjopen-2020-042101 |
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