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DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial
INTRODUCTION: There is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6597655/ https://www.ncbi.nlm.nih.gov/pubmed/31243035 http://dx.doi.org/10.1136/bmjopen-2018-028570 |
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author | Westphal, Glauco Adrieno Robinson, Caroline Cabral Biasi, Alexandre Machado, Flávia Ribeiro Rosa, Regis Goulart Teixeira, Cassiano de Andrade, Joel Franke, Cristiano Augusto Azevedo, Luciano Cesar Pontes Bozza, Fernando Guterres, Cátia Moreira da Silva, Daiana Barbosa Sganzerla, Daniel do Prado, Débora Zechmeister Madalena, Itiana Cardoso Rohden, Adriane Isabel da Silva, Sabrina Souza Giordani, Natalia Elis Andrighetto, Luiza Vitelo Benck, Patrícia Spessatto Roman, Fernando Roberto de Melo, Maria de Fátima Rodrigues Buarque Pereira, Thattyane Borba Grion, Cintia Magalhães Carvalho Diniz, Pedro Carvalho Oliveira, João Fernando Picollo Mecatti, Giovana Colozza Alves, Flávio André Cardona Moraes, Rafael Barberena Nobre, Vandack Hammes, Luciano Serpa Meade, Maureen O Nothen, Rosana Reis Falavigna, Maicon |
author_facet | Westphal, Glauco Adrieno Robinson, Caroline Cabral Biasi, Alexandre Machado, Flávia Ribeiro Rosa, Regis Goulart Teixeira, Cassiano de Andrade, Joel Franke, Cristiano Augusto Azevedo, Luciano Cesar Pontes Bozza, Fernando Guterres, Cátia Moreira da Silva, Daiana Barbosa Sganzerla, Daniel do Prado, Débora Zechmeister Madalena, Itiana Cardoso Rohden, Adriane Isabel da Silva, Sabrina Souza Giordani, Natalia Elis Andrighetto, Luiza Vitelo Benck, Patrícia Spessatto Roman, Fernando Roberto de Melo, Maria de Fátima Rodrigues Buarque Pereira, Thattyane Borba Grion, Cintia Magalhães Carvalho Diniz, Pedro Carvalho Oliveira, João Fernando Picollo Mecatti, Giovana Colozza Alves, Flávio André Cardona Moraes, Rafael Barberena Nobre, Vandack Hammes, Luciano Serpa Meade, Maureen O Nothen, Rosana Reis Falavigna, Maicon |
author_sort | Westphal, Glauco Adrieno |
collection | PubMed |
description | INTRODUCTION: There is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of an evidence-based, goal-directed checklist for brain-dead potential organ donor management in intensive care units (ICUs) in reducing the loss of potential donors due to cardiac arrest. METHODS AND ANALYSIS: The study will include ICUs of at least 60 Brazilian sites with an average of ≥10 annual notifications of valid potential organ donors. Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU. Team members from all participating ICUs will receive training on how to conduct family interviews for organ donation. The primary outcome will be loss of potential donors due to cardiac arrest. Secondary outcomes will include the number of actual organ donors and the number of organs recovered per actual donor. ETHICS AND DISSEMINATION: The institutional review board (IRB) of the coordinating centre and of each participating site individually approved the study. We requested a waiver of informed consent for the IRB of each site. Study results will be disseminated to the general medical community through publications in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT03179020; Pre-results. |
format | Online Article Text |
id | pubmed-6597655 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-65976552019-07-18 DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial Westphal, Glauco Adrieno Robinson, Caroline Cabral Biasi, Alexandre Machado, Flávia Ribeiro Rosa, Regis Goulart Teixeira, Cassiano de Andrade, Joel Franke, Cristiano Augusto Azevedo, Luciano Cesar Pontes Bozza, Fernando Guterres, Cátia Moreira da Silva, Daiana Barbosa Sganzerla, Daniel do Prado, Débora Zechmeister Madalena, Itiana Cardoso Rohden, Adriane Isabel da Silva, Sabrina Souza Giordani, Natalia Elis Andrighetto, Luiza Vitelo Benck, Patrícia Spessatto Roman, Fernando Roberto de Melo, Maria de Fátima Rodrigues Buarque Pereira, Thattyane Borba Grion, Cintia Magalhães Carvalho Diniz, Pedro Carvalho Oliveira, João Fernando Picollo Mecatti, Giovana Colozza Alves, Flávio André Cardona Moraes, Rafael Barberena Nobre, Vandack Hammes, Luciano Serpa Meade, Maureen O Nothen, Rosana Reis Falavigna, Maicon BMJ Open Intensive Care INTRODUCTION: There is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of an evidence-based, goal-directed checklist for brain-dead potential organ donor management in intensive care units (ICUs) in reducing the loss of potential donors due to cardiac arrest. METHODS AND ANALYSIS: The study will include ICUs of at least 60 Brazilian sites with an average of ≥10 annual notifications of valid potential organ donors. Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU. Team members from all participating ICUs will receive training on how to conduct family interviews for organ donation. The primary outcome will be loss of potential donors due to cardiac arrest. Secondary outcomes will include the number of actual organ donors and the number of organs recovered per actual donor. ETHICS AND DISSEMINATION: The institutional review board (IRB) of the coordinating centre and of each participating site individually approved the study. We requested a waiver of informed consent for the IRB of each site. Study results will be disseminated to the general medical community through publications in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT03179020; Pre-results. BMJ Publishing Group 2019-06-25 /pmc/articles/PMC6597655/ /pubmed/31243035 http://dx.doi.org/10.1136/bmjopen-2018-028570 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 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 | Intensive Care Westphal, Glauco Adrieno Robinson, Caroline Cabral Biasi, Alexandre Machado, Flávia Ribeiro Rosa, Regis Goulart Teixeira, Cassiano de Andrade, Joel Franke, Cristiano Augusto Azevedo, Luciano Cesar Pontes Bozza, Fernando Guterres, Cátia Moreira da Silva, Daiana Barbosa Sganzerla, Daniel do Prado, Débora Zechmeister Madalena, Itiana Cardoso Rohden, Adriane Isabel da Silva, Sabrina Souza Giordani, Natalia Elis Andrighetto, Luiza Vitelo Benck, Patrícia Spessatto Roman, Fernando Roberto de Melo, Maria de Fátima Rodrigues Buarque Pereira, Thattyane Borba Grion, Cintia Magalhães Carvalho Diniz, Pedro Carvalho Oliveira, João Fernando Picollo Mecatti, Giovana Colozza Alves, Flávio André Cardona Moraes, Rafael Barberena Nobre, Vandack Hammes, Luciano Serpa Meade, Maureen O Nothen, Rosana Reis Falavigna, Maicon DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial |
title | DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial |
title_full | DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial |
title_fullStr | DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial |
title_full_unstemmed | DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial |
title_short | DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial |
title_sort | donors (donation network to optimise organ recovery study): study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial |
topic | Intensive Care |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6597655/ https://www.ncbi.nlm.nih.gov/pubmed/31243035 http://dx.doi.org/10.1136/bmjopen-2018-028570 |
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