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Donation Network to Optimize Organ Recovery Study

NCT03179020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1535

Last updated 2020-11-02

No results posted yet for this study

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.

Conditions

  • Brain Death
  • Organ Donation

Interventions

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.

OTHER

Usual care

Management of the potential donor according usual care.

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Glauco Westphal, MD, PhD · Hospital Moinhos de Vento

  • Regis G Rosa, MD, PhD · Hospital Moinhos de Vento

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2019-08-28
Completion
2019-08-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03179020 on ClinicalTrials.gov