Donation Network to Optimize Organ Recovery Study
DONORS
Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors
1 other identifier
interventional
1,535
1 country
63
Brief Summary
This study consists in an cluster-randomized clinical trial involving near 60 Brazilian intensive care units (ICUs) with a high notification rate of potential donors of organs and tissues. ICUs will be randomized in a 1:1 ratio to manage potential organ donors through the use of a evidence-based checklist or to manage potential organ donors according usual care. The primary outcome is the rate of losses of potential donors due to cardiac arrest. Secondary outcome measures include number of effective organ donors and number of organs recovery per effective donor. The first subject was enrolled on June 20, 2018.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 7, 2017
CompletedStudy Start
First participant enrolled
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2019
CompletedNovember 2, 2020
October 1, 2020
2.2 years
March 23, 2017
October 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Losses of potential donors due to cardiac arrest
Proportion of losses of potential donors due to cardiac arrest
This event will be evaluated from the date of study subject enrollment until the date of organ recovery or end of brain death protocol (for cases of family refusal or contraindications to organ recovery) assessed up to 14 days
Secondary Outcomes (2)
Effective organ donor
This event will be evaluated from the date of study subject enrollment until the date of organ recovery or end of brain death protocol (for cases of family refusal or contraindications to organ recovery) assessed up to 14 days
Organ recovery per effective donor
This event will be evaluated from the date of study subject enrollment until the date of organ recovery assessed up to 14 days
Study Arms (2)
Checklist ICUs
EXPERIMENTALManagement of the potential donor guided by the use of an evidence-based checklist. This checklist is based on main recommendations of the Brazilian guideline for the management of potential multiple organ donors.
Usual Care ICUs
ACTIVE COMPARATORManagement of the potential donor according usual care.
Interventions
Management of the potential donor guided by the use of an evidence-based checklist. This checklist is based on main recommendations of the Brazilian guideline for the management of potential multiple organ donors.
Eligibility Criteria
You may qualify if:
- For ICUs:
- Adults ICUs reporting at least 10 potential valid donors (without clinical contraindications for donation) per year
- For potential donor:
- Age of 14 years or older
- Suspected brain death after the first clinical test
You may not qualify if:
- For ICUs:
- Coronary units, intermediate units, emergency services
- ICUs that use checklist for the management of the potential donors
- For potential donors:
- Age \>90 years
- HIV
- Metastatic cancer
- Uncontrolled sepsis
- Acute hepatitis
- Malaria
- Acute viral infections
- Cryptococcal meningoencephalitis and prion diseases
- Active tuberculosis treated less than 2 months
- Colonization of the donor by bacteria without any option of antibiotic treatment
- History of breast tumor, melanoma, soft tissue sarcoma or hematologic neoplasia, WHO Group 3 primary tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Moinhos de Ventolead
- Ministry of Health, Brazilcollaborator
Study Sites (63)
Hospital das Clínicas de Rio Branco
Rio Branco, Acre, Brazil
Hospital de Urgência e Emergência de Rio Branco
Rio Branco, Acre, Brazil
Hospital Geral Prof. Osvaldo Brandão Vilela
Maceió, Alagoas, Brazil
Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado
Manaus, Amazonas, Brazil
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
Hospital Insituto Dr José Frota
Fortaleza, Ceará, Brazil
Hospital Regional do Cariri
Juazeiro do Norte, Ceará, Brazil
Hospital Regional Tarcisio de Vasconcelos Maia
Mossoró, Ceará, Brazil
Hospital Regional Norte
Sobral, Ceará, Brazil
Santa Casa de Misericórdia de Sobral
Sobral, Ceará, Brazil
Hospital Estadual de Urgência e Emergência de Vitória
Vitória, Espírito Santo, Brazil
Hospital Geral Cleriston Andrade
Feira de Santana, Estado de Bahia, Brazil
Hospital de Base do Distrito Federal
Brasília, Federal District, Brazil
Hospital de Urgência de Goiânia
Goiânia, Goiás, Brazil
Hospital Dr Carlos Macieira
São Luís, Maranhão, Brazil
Socorrão I - Hospital Municipal Djalma Marques
São Luís, Maranhão, Brazil
Santa Casa de Campo Grande
Campo Grande, Mato Grosso do Sul, Brazil
Hospital das Clinicas das Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital João XXIII Fundação Hospitalar do Estado de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitário Ciências Médicas
Belo Horizonte, Minas Gerais, Brazil
Santa Casa de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Hospital Norte Paranaense
Arapongas, Paraná, Brazil
Hospital e Maternidade Angelina Caron
Campina Grande do Sul, Paraná, 83430-000, Brazil
Hospital Nossa Senhora do Rocio de Campo Largo
Campo Largo, Paraná, Brazil
Hospital Universitário de Cascavel do Oeste do Paraná
Cascavel, Paraná, Brazil
Hospital Municipal Padre Germano Lauk
Foz do Iguaçu, Paraná, 85864-380, Brazil
Hospital São Vicente de Paulo Guarapuava
Guarapuava, Paraná, Brazil
Hospital Evangélico de Londrina
Londrina, Paraná, Brazil
Hospital Universitário Regional do Norte do Paraná
Londrina, Paraná, Brazil
Hospital Santa Rita de Maringá
Maringá, Paraná, Brazil
Hospital Universitário de Maringá
Maringá, Paraná, Brazil
Irmandade Santa Casa de Misericórdia de Maringá
Maringá, Paraná, Brazil
Hospital Bom Jesus de Ponta Grossa
Ponta Grossa, Paraná, Brazil
Hospital Universitario Regional dos Campos Gerais
Ponta Grossa, Paraná, Brazil
Hospital Bom Jesus de Toledo
Toledo, Paraná, Brazil
Alberto Urquiza Wanderley - Unimed João Pessoa
João Pessoa, Paraíba, Brazil
Hospital de Ensino Doutor Washington Antônio de barros
Petrolina, Pernambuco, Brazil
Hospital da Restauração
Recife, Pernambuco, Brazil
Hospital Geral de Nova Iguaçu
Nova Iguaçu, Rio de Janeiro, Brazil
Hospital de Canoas
Canoas, Rio Grande do Sul, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Universitário São Francisco de Paula
Pelotas, Rio Grande do Sul, Brazil
Hospital Cristo Redentor
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Pronto Socorro de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Pronto Socorro João Paulo II
Porto Velho, Rondônia, Brazil
Hospital de Urgência de Sergipe
Aracaju, Sergipe, Brazil
Hospital das Clínicas de Botucatu
Botucatu, São Paulo, Brazil
Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista
Bragança Paulista, São Paulo, Brazil
Hospital Municipal Irmã Dulce
Praia Grande, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Casa de Saúde de Santos
Santos, São Paulo, Brazil
Hospital de Base de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Irmandade Santa Casa de Misericórdia de Sorocaba
Sorocaba, São Paulo, Brazil
Hospital Regional do Vale do Paraíba
Taubaté, São Paulo, Brazil
Hospital Estadual Getúlio Vargas
Rio de Janeiro, Brazil
Hospital Beneficência Portuguesa de São Paulo
São Paulo, Brazil
Hospital Geral de Taipas
São Paulo, Brazil
Hospital Paulistano
São Paulo, Brazil
Hospital São Paulo
São Paulo, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Related Publications (3)
Westphal GA, Robinson CC, Giordani NE, Teixeira C, Rohden AI, Dos Passos Gimenes B, Guterres CM, Madalena IC, Andrighetto LV, Souza da Silva S, Barbosa da Silva D, Sganzerla D, Cavalcanti AB, Franke CA, Bozza FA, Machado FR, de Andrade J, Pontes Azevedo LC, Schneider S, Orlando BR, Grion CMC, Bezerra FA, Roman FR, Leite FO Jr, Ferraz Siqueira IL, Oliveira JFP, de Oliveira LC Jr, de Melo MFRB, Leal PBGP, Diniz PC, Moraes RB, Salomao Pontes DF, Araujo Queiroz JE, Hammes LS, Meade MO, Rosa RG, Falavigna M; DONORS (Donation Network to Optimize Organ Recovery Study) Investigators and the BRICNet (Brazilian Research in Intensive Care Network). Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2346901. doi: 10.1001/jamanetworkopen.2023.46901.
PMID: 38095899DERIVEDGiordani NE, Robinson CC, Westphal GA, Rosa RG, Sganzerla D, Cavalcanti AB, Machado FR, Azevedo LCP, Bozza FA, Teixeira C, de Andrade J, Franke CA, Guterres CM, Madalena IC, Rohden AI, da Silva SS, Andrighetto LV, Rech GS, Gimenes BDP, Hammes LS, Pontes DFS, Meade MO, Falavigna M. 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). Trials. 2020 Jun 17;21(1):540. doi: 10.1186/s13063-020-04457-1.
PMID: 32552839DERIVEDWestphal GA, Robinson CC, Biasi A, Machado FR, Rosa RG, Teixeira C, de Andrade J, Franke CA, Azevedo LCP, Bozza F, Guterres CM, da Silva DB, Sganzerla D, do Prado DZ, Madalena IC, Rohden AI, da Silva SS, Giordani NE, Andrighetto LV, Benck PS, Roman FR, de Melo MFRB, Pereira TB, Grion CMC, Diniz PC, Oliveira JFP, Mecatti GC, Alves FAC, Moraes RB, Nobre V, Hammes LS, Meade MO, Nothen RR, Falavigna M; DONORS (Donation Network to Optimise Organ Recovery Study) Investigators and the BRICNet. 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. BMJ Open. 2019 Jun 25;9(6):e028570. doi: 10.1136/bmjopen-2018-028570.
PMID: 31243035DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Glauco Westphal, MD, PhD
Hospital Moinhos de Vento
- STUDY DIRECTOR
Regis G Rosa, MD, PhD
Hospital Moinhos de Vento
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2017
First Posted
June 7, 2017
Study Start
June 20, 2017
Primary Completion
August 28, 2019
Study Completion
August 28, 2019
Last Updated
November 2, 2020
Record last verified: 2020-10