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Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial
INTRODUCTION: Pancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tran...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640528/ https://www.ncbi.nlm.nih.gov/pubmed/33148764 http://dx.doi.org/10.1136/bmjopen-2020-040914 |
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author | Ishii, Kenta Yokoyama, Yukihiro Yonekawa, Yoshihiko Ebata, Tomoki |
author_facet | Ishii, Kenta Yokoyama, Yukihiro Yonekawa, Yoshihiko Ebata, Tomoki |
author_sort | Ishii, Kenta |
collection | PubMed |
description | INTRODUCTION: Pancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery. Nevertheless, the effect of perioperative TXA use in patients undergoing PD has not been investigated. This study aims to investigate the effect of TXA on blood loss during PD. METHODS AND ANALYSIS: A multicentre (six hospitals), randomised, blind (patient-blinded, surgeon-blinded, anaesthesiologist-blinded, monitor-blinded), placebo-controlled trial of TXA during PD was started in September 2019. Patients undergoing PD for biliary, duodenal or pancreatic diseases are randomly assigned to the TXA or placebo group. The stratification factors are the institutions and preoperative clinical diagnosis. Before skin incision, the participants in TXA group are administrated 1 g TXA as a loading infusion followed by a maintenance infusion of 125 mg/hour TXA until the end of surgery or 8 hours from the incision. Participants in the placebo group are administrated the same volume of saline that is indistinguishable from the TXA. The primary outcome is blood loss during PD. The secondary outcomes are intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day mortality and postoperative complications occurring within 28 days of surgery or requiring readmission. To date, 115 patients of a planned 220 have been enrolled in the study. ETHICS AND DISSEMINATION: This protocol was approved by the Nagoya University Clinical Research Review Board and is registered with Japan Registry of Clinical Trials on 15 August 2019. The results of this trial will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: jRCTs041190062. |
format | Online Article Text |
id | pubmed-7640528 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-76405282020-11-10 Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial Ishii, Kenta Yokoyama, Yukihiro Yonekawa, Yoshihiko Ebata, Tomoki BMJ Open Surgery INTRODUCTION: Pancreaticoduodenectomy (PD) is a major gastroenterological surgery that results in a substantial amount of blood loss. Several studies have demonstrated that major blood loss during PD is associated with both short-term and long-term poor outcomes. Administration of perioperative tranexamic acid (TXA) has been reported to reduce intraoperative blood loss in various surgeries, including cardiovascular surgery and orthopaedic surgery. Nevertheless, the effect of perioperative TXA use in patients undergoing PD has not been investigated. This study aims to investigate the effect of TXA on blood loss during PD. METHODS AND ANALYSIS: A multicentre (six hospitals), randomised, blind (patient-blinded, surgeon-blinded, anaesthesiologist-blinded, monitor-blinded), placebo-controlled trial of TXA during PD was started in September 2019. Patients undergoing PD for biliary, duodenal or pancreatic diseases are randomly assigned to the TXA or placebo group. The stratification factors are the institutions and preoperative clinical diagnosis. Before skin incision, the participants in TXA group are administrated 1 g TXA as a loading infusion followed by a maintenance infusion of 125 mg/hour TXA until the end of surgery or 8 hours from the incision. Participants in the placebo group are administrated the same volume of saline that is indistinguishable from the TXA. The primary outcome is blood loss during PD. The secondary outcomes are intraoperative and postoperative (up to day 2) blood transfusions, operation time, anaesthesia time, postoperative laboratory variables, length of hospital stay, in-hospital and 90-day mortality and postoperative complications occurring within 28 days of surgery or requiring readmission. To date, 115 patients of a planned 220 have been enrolled in the study. ETHICS AND DISSEMINATION: This protocol was approved by the Nagoya University Clinical Research Review Board and is registered with Japan Registry of Clinical Trials on 15 August 2019. The results of this trial will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: jRCTs041190062. BMJ Publishing Group 2020-11-03 /pmc/articles/PMC7640528/ /pubmed/33148764 http://dx.doi.org/10.1136/bmjopen-2020-040914 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 | Surgery Ishii, Kenta Yokoyama, Yukihiro Yonekawa, Yoshihiko Ebata, Tomoki Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial |
title | Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial |
title_full | Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial |
title_fullStr | Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial |
title_full_unstemmed | Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial |
title_short | Tranexamic ACid during PancereaticoDuodenectomy (TAC-PD): study protocol for a multicentre randomised, blind, placebo-controlled trial |
title_sort | tranexamic acid during pancereaticoduodenectomy (tac-pd): study protocol for a multicentre randomised, blind, placebo-controlled trial |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7640528/ https://www.ncbi.nlm.nih.gov/pubmed/33148764 http://dx.doi.org/10.1136/bmjopen-2020-040914 |
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