Donation Network to Optimize Organ Recovery Study

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT03179020

Acronym / sponsor ID

DONORS / DONORS Study

Conditions

Brain Death, Organ Donation

Keywords

Intensive Care Units, Brain Death, Organ Donation, Family interview

Study type

Interventional

Recruitment status

Completed

Enrolment

1,535 participants (actual)

Lead sponsor

Hospital Moinhos de VentoUniversity, hospital or other

Collaborators

Ministry of Health, Brazil

Study start

20 Jun 2017 (actual)

Primary completion

28 Aug 2019 (actual)

Study completion

28 Aug 2019 (actual)

First posted

7 Jun 2017 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Supportive care

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

2

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.

Who may qualify

Ages

14 to 90 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 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

   Proportion of losses of potential donors due to cardiac arrest

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
• Derived from this study: PubMed 38095899Westphal GA, Robinson CC, Giordani NE, Teixeira C, Rohden AI, Dos Passos Gimenes B, Guterres CM, Madalena IC, Andrighetto LV, Souza da Silva S, Barbosa da Silva D, Sganzerla D, Cavalcanti AB, Franke CA, Bozza FA, Machado FR, de Andrade J, Pontes Azevedo LC, Schneider S, Orlando BR, Grion CMC, Bezerra FA, Roman FR, Leite FO Jr, Ferraz Siqueira IL, Oliveira JFP, de Oliveira LC Jr, de Melo MFRB, Leal PBGP, Diniz PC, Moraes RB, Salomao Pontes DF, Araujo Queiroz JE, Hammes LS, Meade MO, Rosa RG, Falavigna M; DONORS (Donation Network to Optimize Organ Recovery Study) Investigators and the BRICNet (Brazilian Research in Intensive Care Network). Evidence-Based Checklist to Delay Cardiac Arrest in Brain-Dead Potential Organ Donors: The DONORS Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Dec 1;6(12):e2346901. doi: 10.1001/jamanetworkopen.2023.46901.
• Derived from this study: PubMed 32552839Giordani NE, Robinson CC, Westphal GA, Rosa RG, Sganzerla D, Cavalcanti AB, Machado FR, Azevedo LCP, Bozza FA, Teixeira C, de Andrade J, Franke CA, Guterres CM, Madalena IC, Rohden AI, da Silva SS, Andrighetto LV, Rech GS, Gimenes BDP, Hammes LS, Pontes DFS, Meade MO, Falavigna M. Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study). Trials. 2020 Jun 17;21(1):540. doi: 10.1186/s13063-020-04457-1.
• Derived from this study: PubMed 31243035Westphal GA, Robinson CC, Biasi A, Machado FR, Rosa RG, Teixeira C, de Andrade J, Franke CA, Azevedo LCP, Bozza F, Guterres CM, da Silva DB, Sganzerla D, do Prado DZ, Madalena IC, Rohden AI, da Silva SS, Giordani NE, Andrighetto LV, Benck PS, Roman FR, de Melo MFRB, Pereira TB, Grion CMC, Diniz PC, Oliveira JFP, Mecatti GC, Alves FAC, Moraes RB, Nobre V, Hammes LS, Meade MO, Nothen RR, Falavigna M; DONORS (Donation Network to Optimise Organ Recovery Study) Investigators and the BRICNet. DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial. BMJ Open. 2019 Jun 25;9(6):e028570. doi: 10.1136/bmjopen-2018-028570.
• Individual participant dataSharing planned: Undecided. The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

63 sites in 1 country: see every site and its status.