Donation Network to Optimize Organ Recovery Study

Not Applicable

Completed

• Conditions: Brain Death; Organ Donation
• Interventions: Other: Checklist use; Other: Usual care

• Registration Number: NCT03179020
• Lead Sponsor: Hospital Moinhos de Vento

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Study Start: 2017-06-20
• Primary Completion: 2019-08-28
• Study Completion: 2019-08-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1535

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Checklist ICUs	Checklist use	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.
Usual Care ICUs	Usual care	Management of the potential donor according usual care.

Primary Outcome Measures

Name	Time	Method
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	Proportion of losses of potential donors due to cardiac arrest

Secondary Outcome Measures

Name	Time	Method
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	Number of organs recovery per effective donor
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	Proportion of Effective organ donors

Trial Locations

Locations (63)

Hospital Universitário Regional do Norte do Paraná; 🇧🇷 Londrina, Paraná, Brazil

Hospital Geral de Taipas; 🇧🇷 São Paulo, Brazil

Hospital de Canoas; 🇧🇷 Canoas, Rio Grande Do Sul, Brazil

Hospital de Ensino Doutor Washington Antônio de barros; 🇧🇷 Petrolina, Pernambuco, Brazil

Irmandade da Santa Casa de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil

Hospital Estadual Getúlio Vargas; 🇧🇷 Rio De Janeiro, Brazil

Hospital Beneficência Portuguesa de São Paulo; 🇧🇷 São Paulo, Brazil

Hospital Paulistano; 🇧🇷 São Paulo, Brazil

Hospital São Paulo; 🇧🇷 São Paulo, Brazil

Hospital Bom Jesus de Ponta Grossa; 🇧🇷 Ponta Grossa, Paraná, Brazil

Hospital São Vicente de Paulo Guarapuava; 🇧🇷 Guarapuava, Paraná, Brazil

Hospital Norte Paranaense; 🇧🇷 Arapongas, Paraná, Brazil

Hospital Regional do Cariri; 🇧🇷 Juazeiro Do Norte, Ceará, Brazil

Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado; 🇧🇷 Manaus, Amazonas, Brazil

Hospital Geral de Fortaleza; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital Regional Tarcisio de Vasconcelos Maia; 🇧🇷 Mossoró, Ceará, Brazil

Hospital Insituto Dr José Frota; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital da Restauração; 🇧🇷 Recife, Pernambuco, Brazil

Santa Casa de Misericórdia de Sobral; 🇧🇷 Sobral, Ceará, Brazil

Hospital Regional Norte; 🇧🇷 Sobral, Ceará, Brazil

Hospital Evangélico de Londrina; 🇧🇷 Londrina, Paraná, Brazil

Hospital Santa Rita de Maringá; 🇧🇷 Maringá, Paraná, Brazil

Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista; 🇧🇷 Bragança Paulista, 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 Municipal Irmã Dulce; 🇧🇷 Praia Grande, São Paulo, Brazil

Irmandade Santa Casa de Misericórdia de Sorocaba; 🇧🇷 Sorocaba, São Paulo, Brazil

Hospital de Base de São José do Rio Preto; 🇧🇷 São José Do Rio Preto, São Paulo, Brazil

Hospital Regional do Vale do Paraíba; 🇧🇷 Taubaté, São Paulo, Brazil

Hospital João XXIII Fundação Hospitalar do Estado de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

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 das Clinicas das 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

Santa Casa de Campo Grande; 🇧🇷 Campo Grande, Mato Grosso Do Sul, Brazil

Hospital Geral de Nova Iguaçu; 🇧🇷 Nova Iguaçu, Rio De Janeiro, Brazil

Hospital Bruno Born; 🇧🇷 Lajeado, 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 Pronto Socorro de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Hospital São Vicente de Paulo; 🇧🇷 Passo Fundo, Rio Grande Do Sul, Brazil

Irmandade da Santa Casa de Misericórdia de São Paulo; 🇧🇷 São Paulo, Brazil

Hospital Geral Cleriston Andrade; 🇧🇷 Feira De Santana, Bahia, Brazil

Hospital de Base do Distrito Federal; 🇧🇷 Brasília, Distrito Federal, Brazil

Hospital de Urgência de Goiânia; 🇧🇷 Goiânia, Goias, Brazil

Hospital Estadual de Urgência e Emergência de Vitória; 🇧🇷 Vitória, Espirito Santo, Brazil

Hospital Dr Carlos Macieira; 🇧🇷 São Luís, MA, Brazil

Socorrão I - Hospital Municipal Djalma Marques; 🇧🇷 São Luís, MA, Brazil

Hospital e Maternidade Angelina Caron; 🇧🇷 Campina Grande do Sul, Paraná, Brazil

Hospital Universitário de Cascavel do Oeste do Paraná; 🇧🇷 Cascavel, Paraná, Brazil

Hospital Nossa Senhora do Rocio de Campo Largo; 🇧🇷 Campo Largo, Paraná, Brazil

Hospital Municipal Padre Germano Lauk; 🇧🇷 Foz do Iguaçu, Paraná, Brazil

Hospital Universitário de Maringá; 🇧🇷 Maringá, Paraná, Brazil

Irmandade Santa Casa de Misericórdia de Maringá; 🇧🇷 Maringá, 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 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