Donation Network to Optimize Organ Recovery Study

Not Applicable

Completed

• Conditions: Brain Death; Organ Donation

• Registration Number: NCT03179020
• Lead Sponsor: Hospital Moinhos de Vento

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-06-05
• Study First Posted: 2017-06-07
• Study Start: 2017-06-20
• Primary Completion: 2019-08-28
• Study Completion: 2019-08-28
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1535

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (63)

Hospital das Clínicas de Rio Branco; 🇧🇷 Rio Branco, Acre, Brazil

Hospital de Urgência e Emergência de Rio Branco; 🇧🇷 Rio Branco, Acre, Brazil

Hospital Geral Prof. Osvaldo Brandão Vilela; 🇧🇷 Maceió, Alagoas, Brazil

Hospital de Pronto Socorro Dr. João Lúcio Pereira Machado; 🇧🇷 Manaus, Amazonas, Brazil

Hospital Geral Cleriston Andrade; 🇧🇷 Feira De Santana, Bahia, Brazil

Hospital Geral de Fortaleza; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital Insituto Dr José Frota; 🇧🇷 Fortaleza, Ceará, Brazil

Hospital Regional do Cariri; 🇧🇷 Juazeiro Do Norte, Ceará, Brazil

Hospital Regional Tarcisio de Vasconcelos Maia; 🇧🇷 Mossoró, Ceará, Brazil

Hospital Regional Norte; 🇧🇷 Sobral, Ceará, Brazil

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