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. 2019 Jun 25;9(6):e028570.
doi: 10.1136/bmjopen-2018-028570.

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  1   2   3 , Caroline Cabral Robinson  1 , Alexandre Biasi  4 , Flávia Ribeiro Machado  5 , Regis Goulart Rosa  6 , Cassiano Teixeira  6   7 , Joel de Andrade  8 , Cristiano Augusto Franke  9   10 , Luciano Cesar Pontes Azevedo  11 , Fernando Bozza  12   13 , Cátia Moreira Guterres  1 , Daiana Barbosa da Silva  6 , Daniel Sganzerla  1 , Débora Zechmeister do Prado  1 , Itiana Cardoso Madalena  1 , Adriane Isabel Rohden  1 , Sabrina Souza da Silva  1 , Natalia Elis Giordani  1   14 , Luiza Vitelo Andrighetto  1 , Patrícia Spessatto Benck  1 , Fernando Roberto Roman  15 , Maria de Fátima Rodrigues Buarque de Melo  16 , Thattyane Borba Pereira  17 , Cintia Magalhães Carvalho Grion  18   19 , Pedro Carvalho Diniz  20 , João Fernando Picollo Oliveira  21 , Giovana Colozza Mecatti  22 , Flávio André Cardona Alves  23 , Rafael Barberena Moraes  9 , Vandack Nobre  24 , Luciano Serpa Hammes  25 , Maureen O Meade  26 , Rosana Reis Nothen  27   28 , Maicon Falavigna  1   14 ; DONORS (Donation Network to Optimise Organ Recovery Study) Investigators and the BRICNet
Collaborators, Affiliations

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 et al. BMJ Open. .

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.

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Conflict of interest statement

Competing interests: None declared.

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).
See this image and copyright information in PMC

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