Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)

Introduction Bleeding during cardiac surgery is associated with increased morbidity and mortality. Tranexamic acid is an antifibrinolytic with proven efficacy in major surgeries. Current clinical practice guidelines recommend intraoperative use in cardiac procedures. However, several complications h...

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Main Authors: Ryan Zarychanski, Bram Rochwerg, Tim Karachi, Alison Fox-Robichaud, Shannon M Fernando, Kwadwo Kyeremanteng, Thamer Alaifan, Ahmed Alenazy, Dominic Xiang Wang, Jessica Spence, Emilie Belley-Cote, Craig Ainswoth, Richard Whitlock
Format: Article
Language:English
Published: BMJ Publishing Group 2019-09-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/9/e028585.full
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author Ryan Zarychanski
Bram Rochwerg
Tim Karachi
Alison Fox-Robichaud
Shannon M Fernando
Kwadwo Kyeremanteng
Thamer Alaifan
Ahmed Alenazy
Dominic Xiang Wang
Jessica Spence
Emilie Belley-Cote
Craig Ainswoth
Richard Whitlock
author_facet Ryan Zarychanski
Bram Rochwerg
Tim Karachi
Alison Fox-Robichaud
Shannon M Fernando
Kwadwo Kyeremanteng
Thamer Alaifan
Ahmed Alenazy
Dominic Xiang Wang
Jessica Spence
Emilie Belley-Cote
Craig Ainswoth
Richard Whitlock
author_sort Ryan Zarychanski
collection DOAJ
description Introduction Bleeding during cardiac surgery is associated with increased morbidity and mortality. Tranexamic acid is an antifibrinolytic with proven efficacy in major surgeries. Current clinical practice guidelines recommend intraoperative use in cardiac procedures. However, several complications have been reported with tranexamic acid including seizures. This review intends to summarise the evidence examining the efficacy and safety of tranexamic acid in patients undergoing cardiac surgery.Methods/design We will search MEDLINE, Embase, PubMED, ACPJC, CINAHL and the Cochrane trial registry for eligible randomised controlled trials, the search dates for all databases will be from inception until 1 January 2019, investigating the perioperative use of topical and/or intravenous tranexamic acid as a stand-alone antifibrinolytic agent compared with placebo in patients undergoing open cardiac surgery. We categorised outcomes as patient critical or patient important. Selected patient-critical outcomes are: mortality (intensive care unit, hospital and 30-day endpoints), reoperation within 24 hours, postoperative bleeding requiring transfusion of packed red blood cells, myocardial infarction, stroke, pulmonary embolism, bowel infarction, upper or lower limb deep vein thrombosis and seizures. Those outcomes, we perceived as clinical experts to be most patient valued and patients were not involved in outcomes selection process. We will not apply publication date, language, journal or methodological quality restrictions. Two reviewers will independently screen and identify eligible studies using predefined eligibility criteria and then review full reports of all potentially relevant citations. A third reviewer will resolve disagreements if consensus cannot be achieved. We will present the results as relative risk with 95% CIs for dichotomous outcomes and as mean difference or standardised mean difference for continuous outcomes with 95% CIs. We will assess the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation approach.Ethics and dissemination Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publicationTrial registration number CRD42018105904
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spelling doaj-art-5275e1498fb641ca90b4d2a7d41ef4f72024-11-23T14:25:12ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2018-028585Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)Ryan Zarychanski0Bram Rochwerg1Tim Karachi2Alison Fox-Robichaud3Shannon M Fernando4Kwadwo Kyeremanteng5Thamer Alaifan6Ahmed Alenazy7Dominic Xiang Wang8Jessica Spence9Emilie Belley-Cote10Craig Ainswoth11Richard Whitlock12Department of Medical Oncology and Hematology, Cancer Care Manitoba, Winnipeg, Manitoba, Canadaassistant professorDepartment of Medicine, McMaster University, Hamilton, Ontario, CanadaMedicine, McMaster University, Hamilton, Ontario, CanadaDivision of Critical Care, Department of Medicine, University of Ottawa, Ottawa, ON, Canadaassistant professorDivision of Critical Care Medicine, Western University, London, Ontario, Canada1 Department of Medicine, Critical Care, McMaster University, Hamilton, Ontario, Canada2 Schulich School of Medicine and Dentistry, University of Western, London, Ontario, Canada4 Departments of Anesthesia and Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada6 Department of Medicine, Critical Care, Cardiology, McMaster University, Hamilton, Ontario, Canada6 Department of Medicine, Critical Care, Cardiology, McMaster University, Hamilton, Ontario, CanadaSurgery, McMaster University Faculty of Health Sciences, Hamilton, Ontario, CanadaIntroduction Bleeding during cardiac surgery is associated with increased morbidity and mortality. Tranexamic acid is an antifibrinolytic with proven efficacy in major surgeries. Current clinical practice guidelines recommend intraoperative use in cardiac procedures. However, several complications have been reported with tranexamic acid including seizures. This review intends to summarise the evidence examining the efficacy and safety of tranexamic acid in patients undergoing cardiac surgery.Methods/design We will search MEDLINE, Embase, PubMED, ACPJC, CINAHL and the Cochrane trial registry for eligible randomised controlled trials, the search dates for all databases will be from inception until 1 January 2019, investigating the perioperative use of topical and/or intravenous tranexamic acid as a stand-alone antifibrinolytic agent compared with placebo in patients undergoing open cardiac surgery. We categorised outcomes as patient critical or patient important. Selected patient-critical outcomes are: mortality (intensive care unit, hospital and 30-day endpoints), reoperation within 24 hours, postoperative bleeding requiring transfusion of packed red blood cells, myocardial infarction, stroke, pulmonary embolism, bowel infarction, upper or lower limb deep vein thrombosis and seizures. Those outcomes, we perceived as clinical experts to be most patient valued and patients were not involved in outcomes selection process. We will not apply publication date, language, journal or methodological quality restrictions. Two reviewers will independently screen and identify eligible studies using predefined eligibility criteria and then review full reports of all potentially relevant citations. A third reviewer will resolve disagreements if consensus cannot be achieved. We will present the results as relative risk with 95% CIs for dichotomous outcomes and as mean difference or standardised mean difference for continuous outcomes with 95% CIs. We will assess the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation approach.Ethics and dissemination Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publicationTrial registration number CRD42018105904https://bmjopen.bmj.com/content/9/9/e028585.full
spellingShingle Ryan Zarychanski
Bram Rochwerg
Tim Karachi
Alison Fox-Robichaud
Shannon M Fernando
Kwadwo Kyeremanteng
Thamer Alaifan
Ahmed Alenazy
Dominic Xiang Wang
Jessica Spence
Emilie Belley-Cote
Craig Ainswoth
Richard Whitlock
Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)
BMJ Open
title Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)
title_full Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)
title_fullStr Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)
title_full_unstemmed Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)
title_short Tranexamic acid in cardiac surgery: a systematic review and meta-analysis (protocol)
title_sort tranexamic acid in cardiac surgery a systematic review and meta analysis protocol
url https://bmjopen.bmj.com/content/9/9/e028585.full
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