DONATE-Pilot Study on ICU Management of Deceased Organ Donors

Study Overview
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Brief Summary
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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
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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. 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); 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. Engage and work with ODOs from each province to foster data sharing and develop procedures to enhance efficiency in future RCTs. 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); 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: Refine data collection procedures for deceased donors in ICU; Estimate time requirements for data collection; Develop efficient links to post-transplantation data and; Share data as it accrues with clinicians.

Official Title
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DONATE-Pilot Study: Prospective Observational Study of the ICU Management of Deceased Organ Donors

Conditions
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Critical Care, Deceased Organ Donors

Intervention / Treatment
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* Other: Data Collection


Participation Criteria
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Eligibility Criteria
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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
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Consented deceased organ donors<br>Data will be collected on deceased donors, declared by neurological determination of death (DND) and by circulatory determination of death (DCD). | Other: Data Collection<br>* Data collection relevant to this study will be obtained by observation and review of hospital charts. Limited data will be obtained through relevant organ donation organizations (ODOs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | This outcome is judged based on four elements: 1) Implementation of a waived consent model; 2) Refinement of data collection procedures for adult intensive care units; 3) Development of efficient links to post-transplantation data. | After 1 year of recruitment at each participating site | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of current practices | A descriptive analysis of various interventions and approaches in the management of deceased organ donors. Adherence to recommendations of the national deceased donor management guidelines. | After 1 year of recruitment at each participating site | 
| Effectiveness of various ICU interventions | Defined as: 1) Number of organs recovered; 2) Number of organs transplanted. | After 1 year of recruitment at each participating site |