DONATE-Pilot Study on ICU Management of Deceased Organ Donors (DONATE-Pilot)

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

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.

Study Overview

• Status: Completed
• Conditions: Critical Care; Deceased Organ Donors
• Intervention / Treatment: Other: Data Collection

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.

• Study Type: Observational
• Enrollment (Actual): 177

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre de recherche CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients for whom consent for deceased organ donation has been obtained.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Consented deceased organ donors; Data will be collected on deceased donors, declared by neurological determination of death (DND) and by circulatory determination of death (DCD).	Other: Data Collection; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian National Transplant Research Program; Canadian Critical Care Trials Group
• Investigators: Principal Investigator: Frederick D'Aragon, MD, MSc, Université de Sherbrooke; Study Director: Meade Maureen, MD, MSc, McMaster University

Publications and helpful links

General Publications

• 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.

Helpful Links

• DONATE Reseearch Progam Website

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 7, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: DONATE-Pilot 14-803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO