- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03179020
Donation Network to Optimize Organ Recovery Study (DONORS)
October 30, 2020 updated by: Hospital Moinhos de Vento
Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1535
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rio De Janeiro, Brazil
- Hospital Estadual Getúlio Vargas
-
São Paulo, Brazil
- Irmandade Da Santa Casa de Misericordia de Sao Paulo
-
São Paulo, Brazil
- Hospital Beneficencia Portuguesa de Sao Paulo
-
São Paulo, Brazil
- Hospital Geral de Taipas
-
São Paulo, Brazil
- Hospital Paulistano
-
São Paulo, Brazil
- Hospital Sao Paulo
-
-
Acre
-
Rio Branco, Acre, Brazil
- Hospital das Clínicas de Rio Branco
-
Rio Branco, Acre, Brazil
- Hospital de Urgência e Emergência de Rio Branco
-
-
Alagoas
-
Maceió, Alagoas, Brazil
- Hospital Geral Prof. Osvaldo Brandão Vilela
-
-
Amazonas
-
Manaus, Amazonas, Brazil
- Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado
-
-
Bahia
-
Feira De Santana, Bahia, Brazil
- Hospital Geral Clériston Andrade
-
-
Ceará
-
Fortaleza, Ceará, Brazil
- Hospital Geral de Fortaleza
-
Fortaleza, Ceará, Brazil
- Hospital Insituto Dr José Frota
-
Juazeiro Do Norte, Ceará, Brazil
- Hospital Regional do Cariri
-
Mossoró, Ceará, Brazil
- Hospital Regional Tarcisio de Vasconcelos Maia
-
Sobral, Ceará, Brazil
- Hospital Regional Norte
-
Sobral, Ceará, Brazil
- Santa Casa de Misericórdia de Sobral
-
-
Distrito Federal
-
Brasília, Distrito Federal, Brazil
- Hospital de Base do Distrito Federal
-
-
Espirito Santo
-
Vitória, Espirito Santo, Brazil
- Hospital Estadual de Urgência e Emergência de Vitória
-
-
Goias
-
Goiânia, Goias, Brazil
- Hospital de Urgência de Goiânia
-
-
MA
-
São Luís, MA, Brazil
- Hospital Dr Carlos Macieira
-
São Luís, MA, Brazil
- Socorrão I - Hospital Municipal Djalma Marques
-
-
Mato Grosso Do Sul
-
Campo Grande, Mato Grosso Do Sul, Brazil
- Santa Casa de Campo Grande
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil
- Hospital Universitário Ciencias Medicas
-
Belo Horizonte, Minas Gerais, 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
- Santa Casa de Belo Horizonte
-
-
Paraná
-
Arapongas, Paraná, Brazil
- Hospital Norte Paranaense
-
Campina Grande do Sul, Paraná, Brazil, 83430-000
- Hospital e Maternidade Angelina Caron
-
Campo Largo, Paraná, Brazil
- Hospital Nossa Senhora do Rocio de Campo Largo
-
Cascavel, Paraná, Brazil
- Hospital Universitário de Cascavel do Oeste do Paraná
-
Foz do Iguaçu, Paraná, Brazil, 85864-380
- Hospital Municipal Padre Germano Lauk
-
Guarapuava, Paraná, Brazil
- Hospital São Vicente de Paulo Guarapuava
-
Londrina, Paraná, Brazil
- Hospital Evangélico de Londrina
-
Londrina, Paraná, Brazil
- Hospital Universitário Regional do Norte do Paraná
-
Maringá, Paraná, Brazil
- Hospital Santa Rita de Maringá
-
Maringá, Paraná, Brazil
- Hospital Universitário de Maringá
-
Maringá, Paraná, Brazil
- Irmandade Santa Casa de Misericórdia de Maringá
-
Ponta Grossa, Paraná, Brazil
- Hospital Bom Jesus de Ponta Grossa
-
Ponta Grossa, Paraná, Brazil
- Hospital Universitario Regional dos Campos Gerais
-
Toledo, Paraná, Brazil
- Hospital Bom Jesus de Toledo
-
-
Paraíba
-
João Pessoa, Paraíba, Brazil
- Alberto Urquiza Wanderley - Unimed João Pessoa
-
-
Pernambuco
-
Petrolina, Pernambuco, Brazil
- Hospital de Ensino Doutor Washington Antônio de barros
-
Recife, Pernambuco, Brazil
- Hospital da Restauração
-
-
RS
-
Porto Alegre, RS, Brazil
- Hospital de Clínicas de Porto Alegre
-
-
Rio De Janeiro
-
Nova Iguaçu, Rio De Janeiro, Brazil
- Hospital Geral de Nova Iguaçu
-
-
Rio Grande Do Sul
-
Canoas, Rio Grande Do Sul, Brazil
- Hospital de Canoas
-
Lajeado, Rio Grande Do Sul, Brazil
- Hospital Bruno Born
-
Passo Fundo, Rio Grande Do Sul, Brazil
- Hospital São Vicente de Paulo
-
Pelotas, Rio Grande Do Sul, Brazil
- Hospital Universitário São Francisco de Paula
-
Porto Alegre, 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
- Irmandade da Santa Casa de Porto Alegre
-
-
Rondônia
-
Porto Velho, Rondônia, Brazil
- Hospital de Pronto Socorro João Paulo II
-
-
Sergipe
-
Aracaju, Sergipe, Brazil
- Hospital de Urgência de Sergipe
-
-
São Paulo
-
Botucatu, São Paulo, Brazil
- Hospital das Clínicas de Botucatu
-
Bragança Paulista, São Paulo, Brazil
- Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista
-
Praia Grande, São Paulo, Brazil
- Hospital Municipal Irmã Dulce
-
Ribeirão Preto, São Paulo, Brazil
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
-
Santos, São Paulo, Brazil
- Casa de Saúde de Santos
-
Sorocaba, São Paulo, Brazil
- Irmandade Santa Casa de Misericórdia de Sorocaba
-
São José Do Rio Preto, São Paulo, Brazil
- Hospital de Base de São José do Rio Preto
-
Taubaté, São Paulo, Brazil
- Hospital Regional do Vale do Paraiba
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Management of the potential donor according usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective organ donor
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
|
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
|
Organ 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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Glauco Westphal, MD, PhD, Hospital Moinhos de Vento
- Study Director: Regis G Rosa, MD, PhD, Hospital Moinhos de Vento
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 20, 2017
Primary Completion (Actual)
August 28, 2019
Study Completion (Actual)
August 28, 2019
Study Registration Dates
First Submitted
March 23, 2017
First Submitted That Met QC Criteria
June 5, 2017
First Posted (Actual)
June 7, 2017
Study Record Updates
Last Update Posted (Actual)
November 2, 2020
Last Update Submitted That Met QC Criteria
October 30, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DONORS Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Death
-
Liu YonghongEnrolling by invitationSudden Unexpected Death in Epilepsy | Near-Sudden Unexpected Death in EpilepsyChina
-
Hospices Civils de LyonTerminatedSudden Unexpected Death in Epilepsy (SUDEP)France
-
Alexandria UniversityUnknownMaternal Death | Hypoxic Brain InjuryEgypt
-
NYU Langone HealthRecruiting
-
Centre Hospitalier Universitaire de NīmesTerminatedStress Disorders, Post-TraumaticFrance
-
Brigham and Women's HospitalNot yet recruitingEpilepsyUnited States
-
Indiana UniversityGreenwich Biosciences; Child Neurology FoundationCompleted
-
Fundació Institut de Recerca de l'Hospital de la...UnknownBiomarkers | Cardiac Sudden Death | Hypoxia Brain | Cell Membrane MicroparticlesSpain
-
Gorm GreisenCopenhagen Trial Unit, Center for Clinical Intervention Research; Elsass FoundationCompletedBrain Injuries | Infant, Extremely Premature | Death; Neonatal | Death, BrainDenmark
-
Instituto de Investigación Hospital Universitario...Hospital de Santa Maria, PortugalCompletedPrevention of Kidney Injury Associated With Brain DeathSpain, Portugal
Clinical Trials on Checklist use
-
RWTH Aachen UniversityCompleted
-
Indonesia UniversityUnknownHypertensionIndonesia
-
University of IowaCompleted
-
Imperial College LondonActive, not recruiting
-
Johns Hopkins UniversityAga Khan University; Fogarty International Center of the National Institute...CompletedHypertension | Hypertensive Emergency | Hypertensive CrisisPakistan
-
University Hospital, Basel, SwitzerlandCompletedElderly Internal Medicine Patients
-
Express CollaborativeKidSIM-ASPIRECompleted
-
Assistance Publique - Hôpitaux de ParisCompletedAmbulatory Surgery ProgrammedFrance
-
Ottawa Hospital Research InstituteCompletedAtrial Fibrillation | Atrial FlutterCanada