RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e028570
DO 10.1136/bmjopen-2018-028570
VO 9
IS 6
A1 Westphal, Glauco Adrieno
A1 Robinson, Caroline Cabral
A1 Biasi, Alexandre
A1 Machado, Flávia Ribeiro
A1 Rosa, Regis Goulart
A1 Teixeira, Cassiano
A1 de Andrade, Joel
A1 Franke, Cristiano Augusto
A1 Azevedo, Luciano Cesar Pontes
A1 Bozza, Fernando
A1 Guterres, Cátia Moreira
A1 da Silva, Daiana Barbosa
A1 Sganzerla, Daniel
A1 do Prado, Débora Zechmeister
A1 Madalena, Itiana Cardoso
A1 Rohden, Adriane Isabel
A1 da Silva, Sabrina Souza
A1 Giordani, Natalia Elis
A1 Andrighetto, Luiza Vitelo
A1 Benck, Patrícia Spessatto
A1 Roman, Fernando Roberto
A1 de Melo, Maria de Fátima Rodrigues Buarque
A1 Pereira, Thattyane Borba
A1 Grion, Cintia Magalhães Carvalho
A1 Diniz, Pedro Carvalho
A1 Oliveira, João Fernando Picollo
A1 Mecatti, Giovana Colozza
A1 Alves, Flávio André Cardona
A1 Moraes, Rafael Barberena
A1 Nobre, Vandack
A1 Hammes, Luciano Serpa
A1 Meade, Maureen O
A1 Nothen, Rosana Reis
A1 Falavigna, Maicon
YR 2019
UL http://bmjopen.bmj.com/content/9/6/e028570.abstract
AB 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.