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Completed

NCT Number: NCT03179020

Donation Network to Optimize Organ Recovery Study

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.

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Key information

Conditions

Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Organ Donation Pathologic Processes Pathological Conditions, Signs and Symptoms Unconsciousness

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas de Rio Branco, Rio Branco, Acre, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Checklist use

Other

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.

Usual Care

Other

Management of the potential donor according usual care.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

Cluster Randomized Trial Evaluating the Implementation of a Evidence Based Checklist for the Management of Potential Organ Donors

Acronym: DONORS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 7, 2017
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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