Donation Network to Optimize Organ Recovery Study

Brain Death Clinical Trial

— DONORS  

Official title:

Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03179020
• Other study ID #: DONORS Study
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: August 28, 2019

Study information

• Verified date: October 2020
• Source: Hospital Moinhos de Vento
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1535
• Est. completion date: August 28, 2019
• Est. primary completion date: August 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Organ Donation

Intervention

Other:
• 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
Management of the potential donor according usual care.

Locations

Country	Name	City	State
Brazil	Hospital de Urgência de Sergipe	Aracaju	Sergipe
Brazil	Hospital Norte Paranaense	Arapongas	Paraná
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 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 de Base do Distrito Federal	Brasília	Distrito Federal
Brazil	Hospital e Maternidade Angelina Caron	Campina Grande do Sul	Paraná
Brazil	Santa Casa de Campo Grande	Campo Grande	Mato Grosso Do Sul
Brazil	Hospital Nossa Senhora do Rocio de Campo Largo	Campo Largo	Paraná
Brazil	Hospital de Canoas	Canoas	Rio Grande Do Sul
Brazil	Hospital Universitário de Cascavel do Oeste do Paraná	Cascavel	Paraná
Brazil	Hospital Geral Cleriston Andrade	Feira De Santana	Bahia
Brazil	Hospital Geral de Fortaleza	Fortaleza	Ceará
Brazil	Hospital Insituto Dr José Frota	Fortaleza	Ceará
Brazil	Hospital Municipal Padre Germano Lauk	Foz do Iguaçu	Paraná
Brazil	Hospital de Urgência de Goiânia	Goiânia	Goias
Brazil	Hospital São Vicente de Paulo Guarapuava	Guarapuava	Paraná
Brazil	Alberto Urquiza Wanderley - Unimed João Pessoa	João Pessoa	Paraíba
Brazil	Hospital Regional do Cariri	Juazeiro Do Norte	Ceará
Brazil	Hospital Bruno Born	Lajeado	Rio Grande Do Sul
Brazil	Hospital Evangélico de Londrina	Londrina	Paraná
Brazil	Hospital Universitário Regional do Norte do Paraná	Londrina	Paraná
Brazil	Hospital Geral Prof. Osvaldo Brandão Vilela	Maceió	Alagoas
Brazil	Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado	Manaus	Amazonas
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 Regional Tarcisio de Vasconcelos Maia	Mossoró	Ceará
Brazil	Hospital Geral de Nova Iguaçu	Nova Iguaçu	Rio De Janeiro
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 de Ensino Doutor Washington Antônio de barros	Petrolina	Pernambuco
Brazil	Hospital Bom Jesus de Ponta Grossa	Ponta Grossa	Paraná
Brazil	Hospital Universitario Regional dos Campos Gerais	Ponta Grossa	Paraná
Brazil	Hospital Cristo Redentor	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS
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 Municipal Irmã Dulce	Praia Grande	São Paulo
Brazil	Hospital da Restauração	Recife	Pernambuco
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto	Ribeirão Preto	São Paulo
Brazil	Hospital das Clínicas de Rio Branco	Rio Branco	Acre
Brazil	Hospital de Urgência e Emergência de Rio Branco	Rio Branco	Acre
Brazil	Hospital Estadual Getúlio Vargas	Rio De Janeiro
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	Hospital Dr Carlos Macieira	São Luís	MA
Brazil	Socorrão I - Hospital Municipal Djalma Marques	São Luís	MA
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	Hospital Regional Norte	Sobral	Ceará
Brazil	Santa Casa de Misericórdia de Sobral	Sobral	Ceará
Brazil	Irmandade Santa Casa de Misericórdia de Sorocaba	Sorocaba	São Paulo
Brazil	Hospital Regional do Vale do Paraíba	Taubaté	São Paulo
Brazil	Hospital Bom Jesus de Toledo	Toledo	Paraná
Brazil	Hospital Estadual de Urgência e Emergência de Vitória	Vitória	Espirito Santo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effective organ donor	Proportion of Effective organ donors	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	Organ recovery per effective donor	Number of organs 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