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

Glauco Adrieno Westphal, Caroline Cabral Robinson, Alexandre Biasi, Flávia Ribeiro Machado, Regis Goulart Rosa, Cassiano Teixeira, Joel de Andrade, Cristiano Augusto Franke, Luciano Cesar Pontes Azevedo, Fernando Bozza, Cátia Moreira Guterres, Daiana Barbosa da Silva, Daniel Sganzerla, Débora Zechmeister do Prado, Itiana Cardoso Madalena, Adriane Isabel Rohden, Sabrina Souza da Silva, Natalia Elis Giordani, Luiza Vitelo Andrighetto, Patrícia Spessatto Benck, Fernando Roberto Roman, Maria de Fátima Rodrigues Buarque de Melo, Thattyane Borba Pereira, Cintia Magalhães Carvalho Grion, Pedro Carvalho Diniz, João Fernando Picollo Oliveira, Giovana Colozza Mecatti, Flávio André Cardona Alves, Rafael Barberena Moraes, Vandack Nobre, Luciano Serpa Hammes, Maureen O Meade, Rosana Reis Nothen, Maicon Falavigna, DONORS (Donation Network to Optimise Organ Recovery Study) Investigators and the BRICNet, Jose Luis Toribio Cuadra, Caroline Luciane De Oliveira, Gabriela Rech, Bruna Dos Passos Gimenes, Iris De Lima Ferraz Siqueira, Aldo Damian Chambi Garrido, Gigliane Maria Angelim de Albuquerque, Régis Augusto Hashimoto, Mateus Roza Teles, Rosely Barreiros Cruz, Nelson Antônio Carneiro Pinheiro Júnior, Janaína Maria Miranda Ferreira de Moraes, Claudete Maria Balzan, Lúcia Regina Arana Leite, Lis Daniela Pinto Oliveira, Edwin Fanola Novillo, Maxwendell Gomes Batista, Silvecler Cortijo De Campos, Marcelo Souza Ferreira, Helen Figueiredo, Nathalia Cristina Moraes, Paulo Henrique Lira Matos, Janaína Feijó, Dernivania De Andrade Ferreira, Ana Paula Rocha Barrel Machado, Poliana Nunes Santos, Lúcio Couto De Oliveira Júnior, Felipe Ferreira Ribeiro de Souza, Daniela Cunha De Oliveira, Graças De Maria Dias Reis, Ana Virgínia Rolim, Lisiane Paiva Alencar, Samira Rocha Magalhães, Eliana Regia Barbosa de Almeida, Joel Isidoro Costa, Larissa Salles Pontes Carneiro, Márcia Maria Vitorino Sampaio Passos, Gustavo Martins Dos Santos, José Wagner Brito de Souza, Bruna Bandeira Oliveira Marinho, Luiz Derwal Salles Júnior, José Henrique Gurgel, Iranildo Passos Fontenele, Layanny Teles Linhares Bezerra, Francisco Olon Leite Júnior, Israel Ferreira Da Costa, Diego Bruno Santos Pinheiro, Denise Martins De Moura, Fernando Albuerne Bezerra, Suzana Cantidio, Jéssica Patrícia Saraiva Medeiros Lima Moreira, Bruna De Sousa Carvalho, Ciro Leite Mendes, Igor Mendonça Do Nascimento, Juliana Sousa Dias, Alexandre Augusto Gomes Alves, Heloisa Rosário Furtado Oliveira Lima, Silvia Helena Cardoso de Araújo Carvalho, Clayton Aragão Magalhães, Marko Antônio Santos, Luiza Maria De Novoa Moraes, Lea Barroso Coutinho Pereira, Henrique Lott Carvalho Novaes Sobrinho, Sylvia Helena Araújo Lima Siqueira, Janaína Rodrigues Da Silva, Samyra Pereira De Moraes, Janaína Correia Walfredo Carvalho, Kátia Regina De Oliveira, Luiz Hamilton Da Silva, Daniela Ferreira Salomão Pontes, Viviane Marçal Da Silva, Camila Vieira Hirata, Jander Pissinate Fornaciari, Ana Paula Neves Curty, Ivens Guimarães Soares, Leandro De Oliveira Ferreira, Alexandre Amaral, Guilherme Ono De Gouvêa, Ana Paula Cordeiro de Menezes Silveira, Frederico Bruzzi De Carvalho, Natasha Preis Ferreira, Sylmara Jenifer Zandona Freitas, Fernanda Coura Pena de Sousa, Laura Chen, Christiane De Freitas Morrão Helt Mantuano Pereira, Amélia Cristina Gomes, Jeova Ferreira De Oliveira, Marcela Leandro Baldow, Rodrigo Santana Dutra, Mara Rubia De Moura, Claudio Dornas De Oliveira, Andressa Siuves Moreira, Marina Ferreira De Oliveira, Patrícia Berg Gonçalves Pereira Leal, Ana Paula Silva das Neves, Rodrigo Correa Gomes da Silva, Márcia Heloisa Flores, Roberto De Almeida, Karin Aline Zili Couto, Alexsandro José Dos Santos Fernandes, Carla Fabíola Carvalho, Elizabeth Regina De Jesus Capelo Frois, Ana Luiza Mezaroba, Josiane Festti, Thomas Markus Dhaese, Simone Macedo Hanke, Guilherme Arcaro, Maikel Ramthun, Jullye Christine Pereira Tomacheski, César Flores, Patrícia Bertoncini Cwiertnia, Péricles Duarte, Elaine Fátima Padilha, Cleber Tchaicka, Lizandra De Oliveira Ayres, Sheila Esteves Farias, Marcos Toshyiuki Tanita, Lucienne Tibery Queiroz Cardoso, Almir Germano, Catia Milene Dell'Agnolo, Rosane Almeida De Freitas, Ellen Sotti Barbosa, Vanessa Martim Mezzavila, Pedro Rigon Junior, Itamar Weiwanko, Cristiano Morginski, Waldir Antonio Pasa Junior, Ricardo Gustavo Zill Risson, Fernanda Gabriella Barbosa Santos, Mayara Ferreira Vieira, Tatiana Euclydes Cassolli, Mariana Pramio Singer, Rosiane De Oliveira Pereira, Jaciara Ribeiro De Oliveira, Melina Almeida Slemer Lemos, Vivianne Cristina Boaretto Toniol, Mariza Aparecida De Souza, Ângelo Yassushi Hayashi, Priscila Lisane De Lima de Paula, Elza De Lara Bezerra, Fernanda Grossmann Ziger Borges, Elaine Silva Ramos, Cibele Aparecida Marochi, Jessyca Braga, Alexander De Oliveira Sodré, Letícia Alves Pereira Entrago, Thiago Matos Barcelos, Roberta Carvalho De Jesus, Vitor Montez, Mônica Silvina França da Silva de Melo, Tais Cristina Benites Vaz, Vladimir Dos Santos, Fábio Fernandes Cardoso, Lucas Mallmann, Adriana Calvi, Nelson Barbosa Franco Neto, Manoel Nelson De Oliveira Silveira, Deisi Fonseca, Susana Santini, Fernanda Paiva Bonow, Ruth Susin, Kellen Patrícia Mayer Machado, Danielle Molardi De Aguiar, Caroline Salim Scheneider, Lidiane Couto Braz, Carlos Francisco Pereira do Bem, Tatiana Helena Rech, Edison Moraes Rodrigues Filho, Vivian Wuerges De Aquino, Fernando Bourscheit, Luciano Marini, Bianca Rodrigues Orlando, Luciano De Oliveira Teixeira, Silvia Zluhan Bizarro, Viviani Aspirot Mendonça, José Oliveira Calvete, Lina Maito, Sabrina Frighetto Henrich, Larissa Assunta Pellizzaro, Thiago Corsi Filiponi, Felipe Fernandes Pires Barbosa, Flávia Gozzoli, André Scazufka Ribeiro, Paulo Henrique Penha Rosateli, Zeher Mohamad Waked, Ana Paula Quintal, Suzana Margareth Ajeje Lobo, Regiane Sampaio, Marcos Morais, James Da Luz Rol, Luciana Da Silva Ferreira, Laercio Martins De Stefano, Marina Acosta Cleto, Silvia Eduara Kenrnely, Cintia Banin, Maria Odila Gomes Douglas, Renato Luis Borba, Daniela Boni, Eliza Maria Prado Monteiro, Airton Leonardo De Oliveira Manoel, Ciro Parioto Neto, Siderleny Casari Martins, Wilson José Lovato, Marcelo Bonvento, Rodrigo Barbosa Cerantola, Leonardo Carvalho Palma, Salomon Ordinola Rojas, Viviane Cordeiro Veiga, Raquel Telles, Phillipe Travassos, Roberto Marco, Fabiano Hirata, Cinthia Consolin Vieira, Ligia Peraza, Miriam Jackiu, Flávio Geraldo Resende Freitas, Alessandra Duarte Santiago, Márcia Rosangela Bertin, Luiz Otsubo, Ana Laura Pinatti Marques, Martha Pereira Torres, Gileade Gomes Dos Santos, Márcia Christina Gomes, Caio Lúcio Soubhia Nunes, Felipe Alves Moreira, Regiane Clelia Ferrari, Daniela Barbosa Ramos, Leny Nascimento Motta Passos, América Carolina Brandão de Melo Sodré, Rita De Cassia Martins Pinto Pedosa, Eliana Regia Barbosa de Almeida, Raquel Duarte Correa Matiello, Maria Dos Santos Machado, Fernando Castro, Gustavo Prudente Gonçalves, Maria Ines Gomes de Oliveira, Omar Lopes Cancado Junior, Claire Carmen Miozzo, Gyanna Lys Melo Moreira Montenegro, Noemy Alencar De Carvalho Gomes, Arlene Teresinha Cagol Garcia Badoch, Rodrigo Alves Sarlo, Gabriel Teixeira E Mello Pereira, Raissa De Medeiros Marques, Suely Lima Araújo Toledo, Ricardo Klein Ruhling, Benito Oliveira Fernandez, Agenor Spalini, Marizete Peixoto Medeiros, Brena Pinheiro Coelho, Joselio Emar De Araújo, Glauco Adrieno Westphal, Caroline Cabral Robinson, Alexandre Biasi, Flávia Ribeiro Machado, Regis Goulart Rosa, Cassiano Teixeira, Joel de Andrade, Cristiano Augusto Franke, Luciano Cesar Pontes Azevedo, Fernando Bozza, Cátia Moreira Guterres, Daiana Barbosa da Silva, Daniel Sganzerla, Débora Zechmeister do Prado, Itiana Cardoso Madalena, Adriane Isabel Rohden, Sabrina Souza da Silva, Natalia Elis Giordani, Luiza Vitelo Andrighetto, Patrícia Spessatto Benck, Fernando Roberto Roman, Maria de Fátima Rodrigues Buarque de Melo, Thattyane Borba Pereira, Cintia Magalhães Carvalho Grion, Pedro Carvalho Diniz, João Fernando Picollo Oliveira, Giovana Colozza Mecatti, Flávio André Cardona Alves, Rafael Barberena Moraes, Vandack Nobre, Luciano Serpa Hammes, Maureen O Meade, Rosana Reis Nothen, Maicon Falavigna, DONORS (Donation Network to Optimise Organ Recovery Study) Investigators and the BRICNet, Jose Luis Toribio Cuadra, Caroline Luciane De Oliveira, Gabriela Rech, Bruna Dos Passos Gimenes, Iris De Lima Ferraz Siqueira, Aldo Damian Chambi Garrido, Gigliane Maria Angelim de Albuquerque, Régis Augusto Hashimoto, Mateus Roza Teles, Rosely Barreiros Cruz, Nelson Antônio Carneiro Pinheiro Júnior, Janaína Maria Miranda Ferreira de Moraes, Claudete Maria Balzan, Lúcia Regina Arana Leite, Lis Daniela Pinto Oliveira, Edwin Fanola Novillo, Maxwendell Gomes Batista, Silvecler Cortijo De Campos, Marcelo Souza Ferreira, Helen Figueiredo, Nathalia Cristina Moraes, Paulo Henrique Lira Matos, Janaína Feijó, Dernivania De Andrade Ferreira, Ana Paula Rocha Barrel Machado, Poliana Nunes Santos, Lúcio Couto De Oliveira Júnior, Felipe Ferreira Ribeiro de Souza, Daniela Cunha De Oliveira, Graças De Maria Dias Reis, Ana Virgínia Rolim, Lisiane Paiva Alencar, Samira Rocha Magalhães, Eliana Regia Barbosa de Almeida, Joel Isidoro Costa, Larissa Salles Pontes Carneiro, Márcia Maria Vitorino Sampaio Passos, Gustavo Martins Dos Santos, José Wagner Brito de Souza, Bruna Bandeira Oliveira Marinho, Luiz Derwal Salles Júnior, José Henrique Gurgel, Iranildo Passos Fontenele, Layanny Teles Linhares Bezerra, Francisco Olon Leite Júnior, Israel Ferreira Da Costa, Diego Bruno Santos Pinheiro, Denise Martins De Moura, Fernando Albuerne Bezerra, Suzana Cantidio, Jéssica Patrícia Saraiva Medeiros Lima Moreira, Bruna De Sousa Carvalho, Ciro Leite Mendes, Igor Mendonça Do Nascimento, Juliana Sousa Dias, Alexandre Augusto Gomes Alves, Heloisa Rosário Furtado Oliveira Lima, Silvia Helena Cardoso de Araújo Carvalho, Clayton Aragão Magalhães, Marko Antônio Santos, Luiza Maria De Novoa Moraes, Lea Barroso Coutinho Pereira, Henrique Lott Carvalho Novaes Sobrinho, Sylvia Helena Araújo Lima Siqueira, Janaína Rodrigues Da Silva, Samyra Pereira De Moraes, Janaína Correia Walfredo Carvalho, Kátia Regina De Oliveira, Luiz Hamilton Da Silva, Daniela Ferreira Salomão Pontes, Viviane Marçal Da Silva, Camila Vieira Hirata, Jander Pissinate Fornaciari, Ana Paula Neves Curty, Ivens Guimarães Soares, Leandro De Oliveira Ferreira, Alexandre Amaral, Guilherme Ono De Gouvêa, Ana Paula Cordeiro de Menezes Silveira, Frederico Bruzzi De Carvalho, Natasha Preis Ferreira, Sylmara Jenifer Zandona Freitas, Fernanda Coura Pena de Sousa, Laura Chen, Christiane De Freitas Morrão Helt Mantuano Pereira, Amélia Cristina Gomes, Jeova Ferreira De Oliveira, Marcela Leandro Baldow, Rodrigo Santana Dutra, Mara Rubia De Moura, Claudio Dornas De Oliveira, Andressa Siuves Moreira, Marina Ferreira De Oliveira, Patrícia Berg Gonçalves Pereira Leal, Ana Paula Silva das Neves, Rodrigo Correa Gomes da Silva, Márcia Heloisa Flores, Roberto De Almeida, Karin Aline Zili Couto, Alexsandro José Dos Santos Fernandes, Carla Fabíola Carvalho, Elizabeth Regina De Jesus Capelo Frois, Ana Luiza Mezaroba, Josiane Festti, Thomas Markus Dhaese, Simone Macedo Hanke, Guilherme Arcaro, Maikel Ramthun, Jullye Christine Pereira Tomacheski, César Flores, Patrícia Bertoncini Cwiertnia, Péricles Duarte, Elaine Fátima Padilha, Cleber Tchaicka, Lizandra De Oliveira Ayres, Sheila Esteves Farias, Marcos Toshyiuki Tanita, Lucienne Tibery Queiroz Cardoso, Almir Germano, Catia Milene Dell'Agnolo, Rosane Almeida De Freitas, Ellen Sotti Barbosa, Vanessa Martim Mezzavila, Pedro Rigon Junior, Itamar Weiwanko, Cristiano Morginski, Waldir Antonio Pasa Junior, Ricardo Gustavo Zill Risson, Fernanda Gabriella Barbosa Santos, Mayara Ferreira Vieira, Tatiana Euclydes Cassolli, Mariana Pramio Singer, Rosiane De Oliveira Pereira, Jaciara Ribeiro De Oliveira, Melina Almeida Slemer Lemos, Vivianne Cristina Boaretto Toniol, Mariza Aparecida De Souza, Ângelo Yassushi Hayashi, Priscila Lisane De Lima de Paula, Elza De Lara Bezerra, Fernanda Grossmann Ziger Borges, Elaine Silva Ramos, Cibele Aparecida Marochi, Jessyca Braga, Alexander De Oliveira Sodré, Letícia Alves Pereira Entrago, Thiago Matos Barcelos, Roberta Carvalho De Jesus, Vitor Montez, Mônica Silvina França da Silva de Melo, Tais Cristina Benites Vaz, Vladimir Dos Santos, Fábio Fernandes Cardoso, Lucas Mallmann, Adriana Calvi, Nelson Barbosa Franco Neto, Manoel Nelson De Oliveira Silveira, Deisi Fonseca, Susana Santini, Fernanda Paiva Bonow, Ruth Susin, Kellen Patrícia Mayer Machado, Danielle Molardi De Aguiar, Caroline Salim Scheneider, Lidiane Couto Braz, Carlos Francisco Pereira do Bem, Tatiana Helena Rech, Edison Moraes Rodrigues Filho, Vivian Wuerges De Aquino, Fernando Bourscheit, Luciano Marini, Bianca Rodrigues Orlando, Luciano De Oliveira Teixeira, Silvia Zluhan Bizarro, Viviani Aspirot Mendonça, José Oliveira Calvete, Lina Maito, Sabrina Frighetto Henrich, Larissa Assunta Pellizzaro, Thiago Corsi Filiponi, Felipe Fernandes Pires Barbosa, Flávia Gozzoli, André Scazufka Ribeiro, Paulo Henrique Penha Rosateli, Zeher Mohamad Waked, Ana Paula Quintal, Suzana Margareth Ajeje Lobo, Regiane Sampaio, Marcos Morais, James Da Luz Rol, Luciana Da Silva Ferreira, Laercio Martins De Stefano, Marina Acosta Cleto, Silvia Eduara Kenrnely, Cintia Banin, Maria Odila Gomes Douglas, Renato Luis Borba, Daniela Boni, Eliza Maria Prado Monteiro, Airton Leonardo De Oliveira Manoel, Ciro Parioto Neto, Siderleny Casari Martins, Wilson José Lovato, Marcelo Bonvento, Rodrigo Barbosa Cerantola, Leonardo Carvalho Palma, Salomon Ordinola Rojas, Viviane Cordeiro Veiga, Raquel Telles, Phillipe Travassos, Roberto Marco, Fabiano Hirata, Cinthia Consolin Vieira, Ligia Peraza, Miriam Jackiu, Flávio Geraldo Resende Freitas, Alessandra Duarte Santiago, Márcia Rosangela Bertin, Luiz Otsubo, Ana Laura Pinatti Marques, Martha Pereira Torres, Gileade Gomes Dos Santos, Márcia Christina Gomes, Caio Lúcio Soubhia Nunes, Felipe Alves Moreira, Regiane Clelia Ferrari, Daniela Barbosa Ramos, Leny Nascimento Motta Passos, América Carolina Brandão de Melo Sodré, Rita De Cassia Martins Pinto Pedosa, Eliana Regia Barbosa de Almeida, Raquel Duarte Correa Matiello, Maria Dos Santos Machado, Fernando Castro, Gustavo Prudente Gonçalves, Maria Ines Gomes de Oliveira, Omar Lopes Cancado Junior, Claire Carmen Miozzo, Gyanna Lys Melo Moreira Montenegro, Noemy Alencar De Carvalho Gomes, Arlene Teresinha Cagol Garcia Badoch, Rodrigo Alves Sarlo, Gabriel Teixeira E Mello Pereira, Raissa De Medeiros Marques, Suely Lima Araújo Toledo, Ricardo Klein Ruhling, Benito Oliveira Fernandez, Agenor Spalini, Marizete Peixoto Medeiros, Brena Pinheiro Coelho, Joselio Emar De Araújo

Abstract

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.

Keywords: brain death; cardiac arrest; checklist; organ donation; quality improvement.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1
Figure 1
Study flow diagram. IRB, Institutional Review Board; No., number.
Figure 2
Figure 2
Logical model for the checklist intervention. ICU, intensive care unit.
Figure 3
Figure 3
Geographical distribution of the participating intensive care units in Brazil. (map base copyright obtained from www.gettyimages.pt).

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