Brain Death, Organ Donation
Conditions
Keywords
Intensive Care Units, Brain Death, Organ Donation, Family interview
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.
Interventions
OTHERUsual care
Management of the potential donor according usual care.
OTHERChecklist 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.
Sponsors
Ministry of Health, Brazil
Hospital Moinhos de Vento
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
14 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Brazil
Outcome results
None listed