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Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial
BACKGROUND: During total aortic arch replacement surgery (TARS) for patients with acute type A aortic dissection, the organs in the lower body, such as the viscera and spinal cord, are at risk of ischemia even when antegrade cerebral perfusion (ACP) is performed. Combining ACP with retrograde inferi...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6480889/ https://www.ncbi.nlm.nih.gov/pubmed/31014386 http://dx.doi.org/10.1186/s13063-019-3319-2 |
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author | Lin, Jing Tan, Zhaoxia Yao, Hao Hu, Xiaolin Zhang, Dafa Zhao, Yuan Xiong, Jiyue Dou, Bo Zhu, Xueshuang Wu, Zhong Guo, Yingqiang Kang, Deying Du, Lei |
author_facet | Lin, Jing Tan, Zhaoxia Yao, Hao Hu, Xiaolin Zhang, Dafa Zhao, Yuan Xiong, Jiyue Dou, Bo Zhu, Xueshuang Wu, Zhong Guo, Yingqiang Kang, Deying Du, Lei |
author_sort | Lin, Jing |
collection | PubMed |
description | BACKGROUND: During total aortic arch replacement surgery (TARS) for patients with acute type A aortic dissection, the organs in the lower body, such as the viscera and spinal cord, are at risk of ischemia even when antegrade cerebral perfusion (ACP) is performed. Combining ACP with retrograde inferior vena caval perfusion (RIVP) during TARS may improve outcomes by providing the lower body with oxygenated blood. METHODS: This study is designed as a multicenter, computer-generated, randomized controlled, assessor-blind, parallel-group study with a superiority framework in patients scheduled for TARS. A total of 636 patients will be randomized on a 1:1 basis to a moderate hypothermia circulatory arrest (MHCA) group, which will receive selective ACP with moderate hypothermia during TARS; or to an RIVP group, which will receive the combination of RIVP and selective ACP under moderate hypothermia during TARS. The primary outcome will be a composite of early mortality and major complications, including paraplegia, postoperative renal failure, severe liver dysfunction, and gastrointestinal complications. All patients will be analyzed according to the intention-to-treat protocol. DISCUSSION: This study aims to assess whether RIVP combined with ACP leads to superior outcomes than ACP alone for patients undergoing TARS under moderate hypothermia. This study seeks to provide high-quality evidence for RIVP to be used in patients with acute type A aortic dissection undergoing TARS. TRIAL REGISTRATION: Clinicaltrials.gov, ID: NCT03607786. Registered on 30 July 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3319-2) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-6480889 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-64808892019-05-02 Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial Lin, Jing Tan, Zhaoxia Yao, Hao Hu, Xiaolin Zhang, Dafa Zhao, Yuan Xiong, Jiyue Dou, Bo Zhu, Xueshuang Wu, Zhong Guo, Yingqiang Kang, Deying Du, Lei Trials Study Protocol BACKGROUND: During total aortic arch replacement surgery (TARS) for patients with acute type A aortic dissection, the organs in the lower body, such as the viscera and spinal cord, are at risk of ischemia even when antegrade cerebral perfusion (ACP) is performed. Combining ACP with retrograde inferior vena caval perfusion (RIVP) during TARS may improve outcomes by providing the lower body with oxygenated blood. METHODS: This study is designed as a multicenter, computer-generated, randomized controlled, assessor-blind, parallel-group study with a superiority framework in patients scheduled for TARS. A total of 636 patients will be randomized on a 1:1 basis to a moderate hypothermia circulatory arrest (MHCA) group, which will receive selective ACP with moderate hypothermia during TARS; or to an RIVP group, which will receive the combination of RIVP and selective ACP under moderate hypothermia during TARS. The primary outcome will be a composite of early mortality and major complications, including paraplegia, postoperative renal failure, severe liver dysfunction, and gastrointestinal complications. All patients will be analyzed according to the intention-to-treat protocol. DISCUSSION: This study aims to assess whether RIVP combined with ACP leads to superior outcomes than ACP alone for patients undergoing TARS under moderate hypothermia. This study seeks to provide high-quality evidence for RIVP to be used in patients with acute type A aortic dissection undergoing TARS. TRIAL REGISTRATION: Clinicaltrials.gov, ID: NCT03607786. Registered on 30 July 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3319-2) contains supplementary material, which is available to authorized users. BioMed Central 2019-04-24 /pmc/articles/PMC6480889/ /pubmed/31014386 http://dx.doi.org/10.1186/s13063-019-3319-2 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Lin, Jing Tan, Zhaoxia Yao, Hao Hu, Xiaolin Zhang, Dafa Zhao, Yuan Xiong, Jiyue Dou, Bo Zhu, Xueshuang Wu, Zhong Guo, Yingqiang Kang, Deying Du, Lei Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial |
title | Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial |
title_full | Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial |
title_fullStr | Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial |
title_full_unstemmed | Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial |
title_short | Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial |
title_sort | retrograde inferior vena caval perfusion for total aortic arch replacement surgery (rivp-tars): study protocol for a multicenter, randomized controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6480889/ https://www.ncbi.nlm.nih.gov/pubmed/31014386 http://dx.doi.org/10.1186/s13063-019-3319-2 |
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