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NCT Number: NCT02902783

DONATE-Pilot Study on 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.

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Key information

Conditions

Deceased Organ Donors Critical Care

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamilton General Hospital, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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).

Primary outcomes

  1. Feasibility

    Time frame: After 1 year of recruitment at each participating site

    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.

Secondary outcomes

  1. Description of current practices

    Time frame: After 1 year of recruitment at each participating site

    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.

  2. Effectiveness of various ICU interventions

    Time frame: After 1 year of recruitment at each participating site

    Defined as: 1) Number of organs recovered; 2) Number of organs transplanted.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Critical Care Trials Group
  • Canadian National Transplant Research Program

Registry information

Official study title

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

Acronym: DONATE-Pilot

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2016
Registry last updated
Mar 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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