Donation Network to Optimize Organ Recovery Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Brain Death, Organ Donation

Intervention / Treatment
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* Other: Checklist use
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Checklist ICUs<br>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<br>* 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.<br>|
| Active Comparator: Usual Care ICUs<br>Management of the potential donor according usual care. | Other: Usual care<br>* Management of the potential donor according usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Losses of potential donors due to cardiac arrest | Proportion of 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective organ donor | Proportion of Effective organ donors | 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 | 
| Organ recovery per effective donor | Number of organs 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family interview, Intensive Care Units, Brain Death, Organ Donation