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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1535

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
      • Rio De Janeiro, Brazil
        • Hospital Estadual Getúlio Vargas
      • São Paulo, Brazil
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo
      • São Paulo, 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
    • 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 Evangelico 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 Sao Jose 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Moinhos de Vento

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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