DONATE-Pilot Study on ICU Management of Deceased Organ Donors

NCT02902783 | Completed

• 1 other identifier: DONATE-Pilot 14-803
• Study Type: observational
• Target: 177
• Locations: 1 country
• Sites: 2

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.

Conditions

Deceased Organ Donors; Critical Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Description of current practices

  After 1 year of recruitment at each participating site

• Effectiveness of various ICU interventions

  After 1 year of recruitment at each participating site

Study Arms (1)

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

Interventions

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).

Consented deceased organ donors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Neonate \<36 weeks gestation

Sponsors & Collaborators

• McMaster University: lead
• Canadian Critical Care Trials Group: collaborator
• Canadian National Transplant Research Program: collaborator

Study Sites (2)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Centre de recherche CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• 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.

  PMID: 29987806 DERIVED

Related Links

• DONATE Reseearch Progam Website

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Meade Maureen, MD, MSc

  McMaster University

  STUDY DIRECTOR

• Frederick D'Aragon, MD, MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 26, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)