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Donation Network to Optimize Organ Recovery Study (DONORS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03179020
Recruitment Status : Completed
First Posted : June 7, 2017
Last Update Posted : November 2, 2020
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital Moinhos de Vento

Study Description
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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
Brain Death Organ Donation Other: Checklist use Other: Usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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.
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 : June 20, 2017
Actual Primary Completion Date : August 28, 2019
Actual Study Completion Date : August 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Organ Donation

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03179020


Locations
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Sponsors and Collaborators
Hospital Moinhos de Vento
Ministry of Health, Brazil
Investigators
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Principal Investigator: Glauco Westphal, MD, PhD Hospital Moinhos de Vento
Study Director: Regis G Rosa, MD, PhD Hospital Moinhos de Vento
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.

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Responsible Party: Hospital Moinhos de Vento
ClinicalTrials.gov Identifier: NCT03179020    
Other Study ID Numbers: DONORS Study
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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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:
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Brain Death
Death
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations