DONORS: Donation Network to Optimize Organ Recovery Study
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Checklist ICUs 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. |
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.
|
Active Comparator: Usual Care ICUs Management of the potential donor according usual care. |
Other: Usual care
Management of the potential donor according usual care.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
For ICUs:
- Adults ICUs reporting at least 10 potential valid donors (without clinical contraindications for donation) per year
For potential donor:
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Age of 14 years or older
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Suspected brain death after the first clinical test
Exclusion Criteria:
For ICUs:
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Coronary units, intermediate units, emergency services
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ICUs that use checklist for the management of the potential donors
For potential donors:
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Age >90 years
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HIV
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Metastatic cancer
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Uncontrolled sepsis
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Acute hepatitis
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Malaria
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Acute viral infections
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Cryptococcal meningoencephalitis and prion diseases
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Active tuberculosis treated less than 2 months
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Colonization of the donor by bacteria without any option of antibiotic treatment
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History of breast tumor, melanoma, soft tissue sarcoma or hematologic neoplasia, WHO Group 3 primary tumors
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital das Clínicas de Rio Branco | Rio Branco | Acre | Brazil | |
2 | Hospital de Urgência e Emergência de Rio Branco | Rio Branco | Acre | Brazil | |
3 | Hospital Geral Prof. Osvaldo Brandão Vilela | Maceió | Alagoas | Brazil | |
4 | Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado | Manaus | Amazonas | Brazil | |
5 | Hospital Geral Cleriston Andrade | Feira De Santana | Bahia | Brazil | |
6 | Hospital Geral de Fortaleza | Fortaleza | Ceará | Brazil | |
7 | Hospital Insituto Dr José Frota | Fortaleza | Ceará | Brazil | |
8 | Hospital Regional do Cariri | Juazeiro Do Norte | Ceará | Brazil | |
9 | Hospital Regional Tarcisio de Vasconcelos Maia | Mossoró | Ceará | Brazil | |
10 | Hospital Regional Norte | Sobral | Ceará | Brazil | |
11 | Santa Casa de Misericórdia de Sobral | Sobral | Ceará | Brazil | |
12 | Hospital de Base do Distrito Federal | Brasília | Distrito Federal | Brazil | |
13 | Hospital Estadual de Urgência e Emergência de Vitória | Vitória | Espirito Santo | Brazil | |
14 | Hospital de Urgência de Goiânia | Goiânia | Goias | Brazil | |
15 | Santa Casa de Campo Grande | Campo Grande | Mato Grosso Do Sul | Brazil | |
16 | Hospital Dr Carlos Macieira | São Luís | MA | Brazil | |
17 | Socorrão I - Hospital Municipal Djalma Marques | São Luís | MA | Brazil | |
18 | Hospital das Clinicas das Minas Gerais | Belo Horizonte | Minas Gerais | Brazil | |
19 | Hospital João XXIII Fundação Hospitalar do Estado de Minas Gerais | Belo Horizonte | Minas Gerais | Brazil | |
20 | Hospital Universitário Ciências Médicas | Belo Horizonte | Minas Gerais | Brazil | |
21 | Santa Casa de Belo Horizonte | Belo Horizonte | Minas Gerais | Brazil | |
22 | Hospital Norte Paranaense | Arapongas | Paraná | Brazil | |
23 | Hospital e Maternidade Angelina Caron | Campina Grande do Sul | Paraná | Brazil | 83430-000 |
24 | Hospital Nossa Senhora do Rocio de Campo Largo | Campo Largo | Paraná | Brazil | |
25 | Hospital Universitário de Cascavel do Oeste do Paraná | Cascavel | Paraná | Brazil | |
26 | Hospital Municipal Padre Germano Lauk | Foz do Iguaçu | Paraná | Brazil | 85864-380 |
27 | Hospital São Vicente de Paulo Guarapuava | Guarapuava | Paraná | Brazil | |
28 | Hospital Evangélico de Londrina | Londrina | Paraná | Brazil | |
29 | Hospital Universitário Regional do Norte do Paraná | Londrina | Paraná | Brazil | |
30 | Hospital Santa Rita de Maringá | Maringá | Paraná | Brazil | |
31 | Hospital Universitário de Maringá | Maringá | Paraná | Brazil | |
32 | Irmandade Santa Casa de Misericórdia de Maringá | Maringá | Paraná | Brazil | |
33 | Hospital Bom Jesus de Ponta Grossa | Ponta Grossa | Paraná | Brazil | |
34 | Hospital Universitario Regional dos Campos Gerais | Ponta Grossa | Paraná | Brazil | |
35 | Hospital Bom Jesus de Toledo | Toledo | Paraná | Brazil | |
36 | Alberto Urquiza Wanderley - Unimed João Pessoa | João Pessoa | Paraíba | Brazil | |
37 | Hospital de Ensino Doutor Washington Antônio de barros | Petrolina | Pernambuco | Brazil | |
38 | Hospital da Restauração | Recife | Pernambuco | Brazil | |
39 | Hospital Geral de Nova Iguaçu | Nova Iguaçu | Rio De Janeiro | Brazil | |
40 | Hospital de Canoas | Canoas | Rio Grande Do Sul | Brazil | |
41 | Hospital Bruno Born | Lajeado | Rio Grande Do Sul | Brazil | |
42 | Hospital São Vicente de Paulo | Passo Fundo | Rio Grande Do Sul | Brazil | |
43 | Hospital Universitário São Francisco de Paula | Pelotas | Rio Grande Do Sul | Brazil | |
44 | Hospital Cristo Redentor | Porto Alegre | Rio Grande Do Sul | Brazil | |
45 | Hospital de Pronto Socorro de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil | |
46 | Irmandade da Santa Casa de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil | |
47 | Hospital de Pronto Socorro João Paulo II | Porto Velho | Rondônia | Brazil | |
48 | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS | Brazil | |
49 | Hospital de Urgência de Sergipe | Aracaju | Sergipe | Brazil | |
50 | Hospital das Clínicas de Botucatu | Botucatu | São Paulo | Brazil | |
51 | Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista | Bragança Paulista | São Paulo | Brazil | |
52 | Hospital Municipal Irmã Dulce | Praia Grande | São Paulo | Brazil | |
53 | Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto | São Paulo | Brazil | |
54 | Casa de Saúde de Santos | Santos | São Paulo | Brazil | |
55 | Irmandade Santa Casa de Misericórdia de Sorocaba | Sorocaba | São Paulo | Brazil | |
56 | Hospital de Base de São José do Rio Preto | São José Do Rio Preto | São Paulo | Brazil | |
57 | Hospital Regional do Vale do Paraíba | Taubaté | São Paulo | Brazil | |
58 | Hospital Estadual Getúlio Vargas | Rio De Janeiro | Brazil | ||
59 | Hospital Beneficência Portuguesa de São Paulo | São Paulo | Brazil | ||
60 | Hospital Geral de Taipas | São Paulo | Brazil | ||
61 | Hospital Paulistano | São Paulo | Brazil | ||
62 | Hospital São Paulo | São Paulo | Brazil | ||
63 | Irmandade da Santa Casa de Misericórdia de São Paulo | São Paulo | Brazil |
Sponsors and Collaborators
- Hospital Moinhos de Vento
- Ministry of Health, Brazil
Investigators
- Principal Investigator: Glauco Westphal, MD, PhD, Hospital Moinhos de Vento
- Study Director: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DONORS Study