Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)

Natalia Elis Giordani, Caroline Cabral Robinson, Glauco Adrieno Westphal, Regis Goulart Rosa, Daniel Sganzerla, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo, Fernando Augusto Bozza, Cassiano Teixeira, Joel de Andrade, Cristiano Augusto Franke, Cátia Moreira Guterres, Itiana Cardoso Madalena, Adriane Isabel Rohden, Sabrina Souza da Silva, Luiza Vitelo Andrighetto, Gabriela Soares Rech, Bruna Dos Passos Gimenes, Luciano Serpa Hammes, Daniela Ferreira Salomão Pontes, Maureen O Meade, Maicon Falavigna, Natalia Elis Giordani, Caroline Cabral Robinson, Glauco Adrieno Westphal, Regis Goulart Rosa, Daniel Sganzerla, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo, Fernando Augusto Bozza, Cassiano Teixeira, Joel de Andrade, Cristiano Augusto Franke, Cátia Moreira Guterres, Itiana Cardoso Madalena, Adriane Isabel Rohden, Sabrina Souza da Silva, Luiza Vitelo Andrighetto, Gabriela Soares Rech, Bruna Dos Passos Gimenes, Luciano Serpa Hammes, Daniela Ferreira Salomão Pontes, Maureen O Meade, Maicon Falavigna

Abstract

Background: The quality of clinical care of brain-dead potential organ donors may help reduce donor losses caused by irreversible or unreversed cardiac arrest and increase the number of organs donated. We sought to determine whether an evidence-based, goal-directed checklist for donor management in intensive care units (ICUs) can reduce donor losses to cardiac arrest.

Methods/design: The DONORS study is a multicentre, cluster-randomised controlled trial with a 1:1 allocation ratio designed to compare an intervention group (goal-directed checklist for brain-dead potential organ donor management) with a control group (standard ICU care). The primary outcome is loss of potential donors due to cardiac arrest. Secondary outcomes are the number of actual organ donors and the number of solid organs recovered per actual donor. Exploratory outcomes include the achievement of relevant clinical goals during the management of brain-dead potential organ donors. The present statistical analysis plan (SAP) describes all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of the trial.

Discussion: The SAP of the DONORS study aims to describe its analytic procedures, enhancing the transparency of the study. At the moment of SAP subsmission, 63 institutions have been randomised and were enrolling study participants. Thus, the analyses reported herein have been defined before the end of the study recruitment and database locking.

Trial registration: ClinicalTrials.gov, NCT03179020. Registered on 7 June 2017.

Keywords: Checklist; Donor management; Donor management goals; Organ donor; Organ transplantation.

Conflict of interest statement

The authors declare that they have no competing interests.

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