Clinical trial NCT03179020: Donation Network to Optimize Organ Recovery Study
Official title: Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Death
Organ Donation
Keywords: Intensive Care Units
Brain Death
Organ Donation
Family interview
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2017-06-07
Enrollment: 1535
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the present study ICUs will be randomized to manage potential organ donors through the use of a evidence-based checklist or to manage potential organ donors according usual care.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Losses of potential donors due to cardiac arrest
timeFrame: 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:
measure: Effective organ donor
timeFrame: 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
measure: Organ recovery per effective donor
timeFrame: This event will be evaluated from the date of study subject enrollment until the date of organ recovery assessed up to 14 days
Other outcomes:
Locations:
city: Rio Branco
country: Brazil
facility: Hospital das Clínicas de Rio Branco
state: Acre
city: Rio Branco
country: Brazil
facility: Hospital de Urgência e Emergência de Rio Branco
state: Acre
city: Maceió
country: Brazil
facility: Hospital Geral Prof. Osvaldo Brandão Vilela
state: Alagoas
city: Manaus
country: Brazil
facility: Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado
state: Amazonas
city: Feira De Santana
country: Brazil
facility: Hospital Geral Cleriston Andrade
state: Bahia
city: Fortaleza
country: Brazil
facility: Hospital Geral de Fortaleza
state: Ceará
city: Fortaleza
country: Brazil
facility: Hospital Insituto Dr José Frota
state: Ceará
city: Juazeiro Do Norte
country: Brazil
facility: Hospital Regional do Cariri
state: Ceará
city: Mossoró
country: Brazil
facility: Hospital Regional Tarcisio de Vasconcelos Maia
state: Ceará
city: Sobral
country: Brazil
facility: Hospital Regional Norte
state: Ceará
city: Sobral
country: Brazil
facility: Santa Casa de Misericórdia de Sobral
state: Ceará
city: Brasília
country: Brazil
facility: Hospital de Base do Distrito Federal
state: Distrito Federal
city: Vitória
country: Brazil
facility: Hospital Estadual de Urgência e Emergência de Vitória
state: Espirito Santo
city: Goiânia
country: Brazil
facility: Hospital de Urgência de Goiânia
state: Goias
city: Campo Grande
country: Brazil
facility: Santa Casa de Campo Grande
state: Mato Grosso Do Sul
city: São Luís
country: Brazil
facility: Hospital Dr Carlos Macieira
state: MA
city: São Luís
country: Brazil
facility: Socorrão I - Hospital Municipal Djalma Marques
state: MA
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas das Minas Gerais
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital João XXIII Fundação Hospitalar do Estado de Minas Gerais
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Hospital Universitário Ciências Médicas
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Belo Horizonte
state: Minas Gerais
city: Arapongas
country: Brazil
facility: Hospital Norte Paranaense
state: Paraná
city: Campina Grande do Sul
country: Brazil
facility: Hospital e Maternidade Angelina Caron
state: Paraná
city: Campo Largo
country: Brazil
facility: Hospital Nossa Senhora do Rocio de Campo Largo
state: Paraná
city: Cascavel
country: Brazil
facility: Hospital Universitário de Cascavel do Oeste do Paraná
state: Paraná
city: Foz do Iguaçu
country: Brazil
facility: Hospital Municipal Padre Germano Lauk
state: Paraná
city: Guarapuava
country: Brazil
facility: Hospital São Vicente de Paulo Guarapuava
state: Paraná
city: Londrina
country: Brazil
facility: Hospital Evangélico de Londrina
state: Paraná
city: Londrina
country: Brazil
facility: Hospital Universitário Regional do Norte do Paraná
state: Paraná
city: Maringá
country: Brazil
facility: Hospital Santa Rita de Maringá
state: Paraná
city: Maringá
country: Brazil
facility: Hospital Universitário de Maringá
state: Paraná
city: Maringá
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de Maringá
state: Paraná
city: Ponta Grossa
country: Brazil
facility: Hospital Bom Jesus de Ponta Grossa
state: Paraná
city: Ponta Grossa
country: Brazil
facility: Hospital Universitario Regional dos Campos Gerais
state: Paraná
city: Toledo
country: Brazil
facility: Hospital Bom Jesus de Toledo
state: Paraná
city: João Pessoa
country: Brazil
facility: Alberto Urquiza Wanderley - Unimed João Pessoa
state: Paraíba
city: Petrolina
country: Brazil
facility: Hospital de Ensino Doutor Washington Antônio de barros
state: Pernambuco
city: Recife
country: Brazil
facility: Hospital da Restauração
state: Pernambuco
city: Nova Iguaçu
country: Brazil
facility: Hospital Geral de Nova Iguaçu
state: Rio De Janeiro
city: Canoas
country: Brazil
facility: Hospital de Canoas
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Hospital Universitário São Francisco de Paula
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Cristo Redentor
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Pronto Socorro de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Porto Alegre
state: Rio Grande Do Sul
city: Porto Velho
country: Brazil
facility: Hospital de Pronto Socorro João Paulo II
state: Rondônia
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Aracaju
country: Brazil
facility: Hospital de Urgência de Sergipe
state: Sergipe
city: Botucatu
country: Brazil
facility: Hospital das Clínicas de Botucatu
state: São Paulo
city: Bragança Paulista
country: Brazil
facility: Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista
state: São Paulo
city: Praia Grande
country: Brazil
facility: Hospital Municipal Irmã Dulce
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
state: São Paulo
city: Santos
country: Brazil
facility: Casa de Saúde de Santos
state: São Paulo
city: Sorocaba
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de Sorocaba
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Hospital de Base de São José do Rio Preto
state: São Paulo
city: Taubaté
country: Brazil
facility: Hospital Regional do Vale do Paraíba
state: São Paulo
city: Rio De Janeiro
country: Brazil
facility: Hospital Estadual Getúlio Vargas
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: Hospital Geral de Taipas
city: São Paulo
country: Brazil
facility: Hospital Paulistano
city: São Paulo
country: Brazil
facility: Hospital São Paulo
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
Study officials:
affiliation: Hospital Moinhos de Vento
name: Glauco Westphal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Moinhos de Vento
name: Regis G Rosa, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Giordani 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.
citation: Westphal 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.