An interventional study of Checklist use and Usual care in Brain Death and Organ Donation, sponsored by Hospital Moinhos de Vento. Completed at 63 sites in Brazil. Open to participants aged 14 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-11-02.
Sponsored by Hospital Moinhos de Vento · Not applicable, Interventional, and Supportive care
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.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 1,535 is above the median of 154 across 39 interventional studies indexed under Brain Death.
Browse Brain Death studies →Hospital Moinhos de Vento is the lead sponsor of 34 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For ICUs:
For potential donor:
Exclusion Criteria:
For ICUs:
For potential donors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Management of the potential donor according usual care.
Other: Usual care
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.
Management of the potential donor according usual care.
Losses of potential donors due to cardiac arrest
Proportion of losses of potential donors due to cardiac arrest
Time frame: 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
Effective organ donor
Proportion of Effective organ donors
Time frame: 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
Time frame: This event will be evaluated from the date of study subject enrollment until the date of organ recovery assessed up to 14 days
Plan to share: Undecided — The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Ran from Jun 2017 to primary completion in Aug 2019, 26 months.
Of 14 interventional studies with no phase under Brain Death, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 52. This study's 26 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Hospital Moinhos de Vento