Donation Network to Optimize Organ Recovery Study (DONORS)

Hospital Moinhos de Vento

Status: Completed

Conditions: Organ Donation; Brain Death

Treatments: Other: Usual care; Other: Checklist use

Study type: Interventional

Funder types: Other

Identifiers

NCT03179020

DONORS Study

Details and patient eligibility

About

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.

Enrollment: 1,535 patients

Sex: All

Ages: 14 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,535 participants in 2 patient groups

Checklist ICUs

Experimental group

Description:

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.

Treatment:

Other: Checklist use

Usual Care ICUs

Active Comparator group

Description:

Management of the potential donor according usual care.

Treatment:

Other: Usual care