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Donation Network to Optimize Organ Recovery Study (DONORS)

Primary Purpose

Brain Death, Organ Donation

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Checklist use
Usual care
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Death focused on measuring Intensive Care Units, Brain Death, Organ Donation, Family interview

Eligibility Criteria

14 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital das Clínicas de Rio Branco
  • Hospital de Urgência e Emergência de Rio Branco
  • Hospital Geral Prof. Osvaldo Brandão Vilela
  • Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado
  • Hospital Geral Cleriston Andrade
  • Hospital Geral de Fortaleza
  • Hospital Insituto Dr José Frota
  • Hospital Regional do Cariri
  • Hospital Regional Tarcisio de Vasconcelos Maia
  • Hospital Regional Norte
  • Santa Casa de Misericórdia de Sobral
  • Hospital de Base do Distrito Federal
  • Hospital Estadual de Urgência e Emergência de Vitória
  • Hospital de Urgência de Goiânia
  • Santa Casa de Campo Grande
  • Hospital Dr Carlos Macieira
  • Socorrão I - Hospital Municipal Djalma Marques
  • Hospital das Clinicas das Minas Gerais
  • Hospital João XXIII Fundação Hospitalar do Estado de Minas Gerais
  • Hospital Universitário Ciências Médicas
  • Santa Casa de Belo Horizonte
  • Hospital Norte Paranaense
  • Hospital e Maternidade Angelina Caron
  • Hospital Nossa Senhora do Rocio de Campo Largo
  • Hospital Universitário de Cascavel do Oeste do Paraná
  • Hospital Municipal Padre Germano Lauk
  • Hospital São Vicente de Paulo Guarapuava
  • Hospital Evangélico de Londrina
  • Hospital Universitário Regional do Norte do Paraná
  • Hospital Santa Rita de Maringá
  • Hospital Universitário de Maringá
  • Irmandade Santa Casa de Misericórdia de Maringá
  • Hospital Bom Jesus de Ponta Grossa
  • Hospital Universitario Regional dos Campos Gerais
  • Hospital Bom Jesus de Toledo
  • Alberto Urquiza Wanderley - Unimed João Pessoa
  • Hospital de Ensino Doutor Washington Antônio de barros
  • Hospital da Restauração
  • Hospital Geral de Nova Iguaçu
  • Hospital de Canoas
  • Hospital Bruno Born
  • Hospital São Vicente de Paulo
  • Hospital Universitário São Francisco de Paula
  • Hospital Cristo Redentor
  • Hospital de Pronto Socorro de Porto Alegre
  • Irmandade da Santa Casa de Porto Alegre
  • Hospital de Pronto Socorro João Paulo II
  • Hospital de Clínicas de Porto Alegre
  • Hospital de Urgência de Sergipe
  • Hospital das Clínicas de Botucatu
  • Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista
  • Hospital Municipal Irmã Dulce
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  • Casa de Saúde de Santos
  • Irmandade Santa Casa de Misericórdia de Sorocaba
  • Hospital de Base de São José do Rio Preto
  • Hospital Regional do Vale do Paraíba
  • Hospital Estadual Getúlio Vargas
  • Hospital Beneficência Portuguesa de São Paulo
  • Hospital Geral de Taipas
  • Hospital Paulistano
  • Hospital São Paulo
  • Irmandade da Santa Casa de Misericórdia de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Checklist ICUs

Usual Care ICUs

Arm Description

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.

Management of the potential donor according usual care.

Outcomes

Primary Outcome Measures

Losses of potential donors due to cardiac arrest
Proportion of losses of potential donors due to cardiac arrest

Secondary Outcome Measures

Effective organ donor
Proportion of Effective organ donors
Organ recovery per effective donor
Number of organs recovery per effective donor

Full Information

First Posted
March 23, 2017
Last Updated
October 30, 2020
Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT03179020
Brief Title
Donation Network to Optimize Organ Recovery Study
Acronym
DONORS
Official Title
Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death, Organ Donation
Keywords
Intensive Care Units, Brain Death, Organ Donation, Family interview

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1535 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Checklist ICUs
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care ICUs
Arm Type
Active Comparator
Arm Description
Management of the potential donor according usual care.
Intervention Type
Other
Intervention Name(s)
Checklist use
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Management of the potential donor according usual care.
Primary Outcome Measure Information:
Title
Losses of potential donors due to cardiac arrest
Description
Proportion of losses of potential donors due to cardiac arrest
Time Frame
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 Outcome Measure Information:
Title
Effective organ donor
Description
Proportion of Effective organ donors
Time Frame
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
Title
Organ recovery per effective donor
Description
Number of organs recovery per effective donor
Time Frame
This event will be evaluated from the date of study subject enrollment until the date of organ recovery assessed up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glauco Westphal, MD, PhD
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Regis G Rosa, MD, PhD
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Study Director
Facility Information:
Facility Name
Hospital das Clínicas de Rio Branco
City
Rio Branco
State/Province
Acre
Country
Brazil
Facility Name
Hospital de Urgência e Emergência de Rio Branco
City
Rio Branco
State/Province
Acre
Country
Brazil
Facility Name
Hospital Geral Prof. Osvaldo Brandão Vilela
City
Maceió
State/Province
Alagoas
Country
Brazil
Facility Name
Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado
City
Manaus
State/Province
Amazonas
Country
Brazil
Facility Name
Hospital Geral Cleriston Andrade
City
Feira De Santana
State/Province
Bahia
Country
Brazil
Facility Name
Hospital Geral de Fortaleza
City
Fortaleza
State/Province
Ceará
Country
Brazil
Facility Name
Hospital Insituto Dr José Frota
City
Fortaleza
State/Province
Ceará
Country
Brazil
Facility Name
Hospital Regional do Cariri
City
Juazeiro Do Norte
State/Province
Ceará
Country
Brazil
Facility Name
Hospital Regional Tarcisio de Vasconcelos Maia
City
Mossoró
State/Province
Ceará
Country
Brazil
Facility Name
Hospital Regional Norte
City
Sobral
State/Province
Ceará
Country
Brazil
Facility Name
Santa Casa de Misericórdia de Sobral
City
Sobral
State/Province
Ceará
Country
Brazil
Facility Name
Hospital de Base do Distrito Federal
City
Brasília
State/Province
Distrito Federal
Country
Brazil
Facility Name
Hospital Estadual de Urgência e Emergência de Vitória
City
Vitória
State/Province
Espirito Santo
Country
Brazil
Facility Name
Hospital de Urgência de Goiânia
City
Goiânia
State/Province
Goias
Country
Brazil
Facility Name
Santa Casa de Campo Grande
City
Campo Grande
State/Province
Mato Grosso Do Sul
Country
Brazil
Facility Name
Hospital Dr Carlos Macieira
City
São Luís
State/Province
MA
Country
Brazil
Facility Name
Socorrão I - Hospital Municipal Djalma Marques
City
São Luís
State/Province
MA
Country
Brazil
Facility Name
Hospital das Clinicas das Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital João XXIII Fundação Hospitalar do Estado de Minas Gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital Universitário Ciências Médicas
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Santa Casa de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Hospital Norte Paranaense
City
Arapongas
State/Province
Paraná
Country
Brazil
Facility Name
Hospital e Maternidade Angelina Caron
City
Campina Grande do Sul
State/Province
Paraná
ZIP/Postal Code
83430-000
Country
Brazil
Facility Name
Hospital Nossa Senhora do Rocio de Campo Largo
City
Campo Largo
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Universitário de Cascavel do Oeste do Paraná
City
Cascavel
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Municipal Padre Germano Lauk
City
Foz do Iguaçu
State/Province
Paraná
ZIP/Postal Code
85864-380
Country
Brazil
Facility Name
Hospital São Vicente de Paulo Guarapuava
City
Guarapuava
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Evangélico de Londrina
City
Londrina
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Universitário Regional do Norte do Paraná
City
Londrina
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Santa Rita de Maringá
City
Maringá
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Universitário de Maringá
City
Maringá
State/Province
Paraná
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericórdia de Maringá
City
Maringá
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Bom Jesus de Ponta Grossa
City
Ponta Grossa
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Universitario Regional dos Campos Gerais
City
Ponta Grossa
State/Province
Paraná
Country
Brazil
Facility Name
Hospital Bom Jesus de Toledo
City
Toledo
State/Province
Paraná
Country
Brazil
Facility Name
Alberto Urquiza Wanderley - Unimed João Pessoa
City
João Pessoa
State/Province
Paraíba
Country
Brazil
Facility Name
Hospital de Ensino Doutor Washington Antônio de barros
City
Petrolina
State/Province
Pernambuco
Country
Brazil
Facility Name
Hospital da Restauração
City
Recife
State/Province
Pernambuco
Country
Brazil
Facility Name
Hospital Geral de Nova Iguaçu
City
Nova Iguaçu
State/Province
Rio De Janeiro
Country
Brazil
Facility Name
Hospital de Canoas
City
Canoas
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital Bruno Born
City
Lajeado
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital São Vicente de Paulo
City
Passo Fundo
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital Universitário São Francisco de Paula
City
Pelotas
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital Cristo Redentor
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital de Pronto Socorro de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Irmandade da Santa Casa de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil
Facility Name
Hospital de Pronto Socorro João Paulo II
City
Porto Velho
State/Province
Rondônia
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital de Urgência de Sergipe
City
Aracaju
State/Province
Sergipe
Country
Brazil
Facility Name
Hospital das Clínicas de Botucatu
City
Botucatu
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista
City
Bragança Paulista
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Municipal Irmã Dulce
City
Praia Grande
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Casa de Saúde de Santos
City
Santos
State/Province
São Paulo
Country
Brazil
Facility Name
Irmandade Santa Casa de Misericórdia de Sorocaba
City
Sorocaba
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital de Base de São José do Rio Preto
City
São José Do Rio Preto
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Regional do Vale do Paraíba
City
Taubaté
State/Province
São Paulo
Country
Brazil
Facility Name
Hospital Estadual Getúlio Vargas
City
Rio De Janeiro
Country
Brazil
Facility Name
Hospital Beneficência Portuguesa de São Paulo
City
São Paulo
Country
Brazil
Facility Name
Hospital Geral de Taipas
City
São Paulo
Country
Brazil
Facility Name
Hospital Paulistano
City
São Paulo
Country
Brazil
Facility Name
Hospital São Paulo
City
São Paulo
Country
Brazil
Facility Name
Irmandade da Santa Casa de Misericórdia de São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
32552839
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.
Results Reference
derived
PubMed Identifier
31243035
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.
Results Reference
derived

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Donation Network to Optimize Organ Recovery Study

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