Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02902783
Recruitment Status : Completed
First Posted : September 16, 2016
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
Canadian Critical Care Trials Group
Canadian National Transplant Research Program
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment
Deceased Organ Donors Critical Care 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 177 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: DONATE-Pilot Study: Prospective Observational Study of the ICU Management of Deceased Organ Donors
Study Start Date : September 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients for whom consent for deceased organ donation has been obtained.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902783


Locations
Layout table for location information
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Canada, Quebec
Centre de recherche CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
McMaster University
Canadian Critical Care Trials Group
Canadian National Transplant Research Program
Investigators
Layout table for investigator information
Study Director: Meade Maureen, MD, MSc McMaster University
Principal Investigator: Frederick D'Aragon, MD, MSc Université de Sherbrooke
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02902783    
Other Study ID Numbers: DONATE-Pilot 14-803
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Death
Pathologic Processes