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DONORS: Donation Network to Optimize Organ Recovery Study

Sponsor
Hospital Moinhos de Vento (Other)
Overall Status
Completed
CT.gov ID
NCT03179020
Collaborator
Ministry of Health, Brazil (Other)
1,535
Enrollment
63
Locations
2
Arms
26.3
Actual Duration (Months)
24.4
Patients Per Site
0.9
Patients Per Site Per Month

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
  • Other: Checklist use
  • Other: Usual care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1535 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Supportive Care
Official Title:
Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors
Actual Study Start Date :
Jun 20, 2017
Actual Primary Completion Date :
Aug 28, 2019
Actual Study Completion Date :
Aug 28, 2019

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

  1. 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

  1. 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

  2. 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

Ages Eligible for Study:
14 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Hospital Moinhos de Vento
ClinicalTrials.gov Identifier:
NCT03179020
Other Study ID Numbers:
  • DONORS Study
First Posted:
Jun 7, 2017
Last Update Posted:
Nov 2, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Moinhos de Vento
Intensive Care Units
Brain Death
Organ Donation
Family interview
Additional relevant MeSH terms:
Brain Death

Study Results

No Results Posted as of Nov 2, 2020