Clinical trial NCT02902783: DONATE-Pilot Study on ICU Management of Deceased Organ Donors
Official title: DONATE-Pilot Study: Prospective Observational Study of the ICU Management of Deceased Organ Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deceased Organ Donors
Critical Care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Critical Care Trials Group
name: Canadian National Transplant Research Program
First posted: 2016-09-16
Enrollment: 177
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients for whom consent for deceased organ donation has been obtained.

Brief summary: The DONATE-Pilot is a prospective observational cohort study in organ donation (OD) that observes the ICU management of consented deceased organ donors at 4 high volume centres over a period of 12 months each. The pilot study will be followed by a 1-year prospective national observational study a 15-20 ICUs across Canada.

Detailed description: This prospective observational cohort pilot study enrols consented organ donors admitted to 4 high volume centres over a period of 12 months. Various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery.

The main objectives of the DONATE-Pilot reflect the objectives of the national study which correspond to the steps in developing a platform for future clinical trials.

1. Form research teams at participating ICUs that will include an ICU physician-researcher, a local organ donation champion, ICU research coordinators and (in a limited role) a local coordinator from the provincial Organ Donation Organization (ODO);
2. Observe, record, and describe ICU practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future RCTs.
3. Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs.
4. Investigate the comparative effectiveness of various ICU interventions in deceased donor care (e.g. the potential for hormonal therapies to improve transplant rates, the potential of heparin therapy to improve peri-operative graft function);
5. Produce specific knowledge translation tools that will serve in the future as both clinical tools to enhance ICU care and research tools to facilitate future RCTs.

As part of the DONATE-Pilot we also aim to assess feasibility. Specifically the objectives are to:

1. Refine data collection procedures for deceased donors in ICU;
2. Estimate time requirements for data collection;
3. Develop efficient links to post-transplantation data and;
4. Share data as it accrues with clinicians.

Eligibility criteria: Inclusion Criteria:

* Admitted to a critical care area (ICU, PICU, CCU, ER)
* Consented deceased organ donors (DND and DCD)

Exclusion Criteria:

* Neonate \<36 weeks gestation

Primary outcomes:
measure: Feasibility
timeFrame: After 1 year of recruitment at each participating site
Secondary outcomes:
measure: Description of current practices
timeFrame: After 1 year of recruitment at each participating site
measure: Effectiveness of various ICU interventions
timeFrame: After 1 year of recruitment at each participating site
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre de recherche CHUS
state: Quebec
Study officials:
affiliation: McMaster University
name: Meade Maureen, MD, MSc
role: STUDY_DIRECTOR
affiliation: Université de Sherbrooke
name: Frederick D'Aragon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Aragon F, Cook D, Dhanani S, Ribic C, Burns KEA, Akhtar A, Hand L, Arseneau E, Cupido C, Whittigham H, Healey A, Frenette AJ, Lamontagne F, Meade MO; Canadian Critical Care Trials Group and the Canadian National Transplant Research Program. Hamilton-DONATE: a city-wide pilot observational study of the ICU management of deceased organ donors. Can J Anaesth. 2018 Oct;65(10):1110-1119. doi: 10.1007/s12630-018-1179-y. Epub 2018 Jul 9.