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Uncontrolled Donation After Circulatory Determination of Death (uDCDD) (uDCDD)

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ClinicalTrials.gov Identifier: NCT03935230
Recruitment Status : Completed
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

Brief Summary:
World-wide, patients waiting for organ transplantation exceed the number of organs available. Many European countries have a uDCDD program which contribute to 10-15% of the donor pool. In Canada, this type of program does not exist. The purpose of this study is to report how many deceased person fulfill the criteria for uncontrolled DCDD in a Canadian medical center.

Condition or disease
Uncontrolled Donation After Circulatory Determination of Death

Detailed Description:
While transplantation has become the definitive treatment for many people suffering end-stage organ failure, demand exceeds supply. For many years, donation after neurological death represented the principal source of organs for transplantation. In the last decade, prevention measures, improvements in neurocritical care, and decompressive craniectomy have led to a significant decrease in the number of non-directed donors (NDDs). In such situations, alternative sources for organ donation must be identified. Cardiac-arrest patients could provide a solution to this organ shortage. Patients who have experienced unexpected in or out of hospital cardiopulmonary arrest could become organ donors. Organ donation following uncontrolled cardiocirculatory death is currently practiced in many European countries. However, in Canada, it's not yet authorized. Yet, each deceased could save up to four lives. The purpose of this study is to determine the organ potential for a cohort of patient who had died from a cardiopulmonary arrest at the CHUS in 2015 and assess the effect of the implementation of a uDCD program on the number of additional donors.

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Study Type : Observational
Actual Enrollment : 1111 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Uncontrolled Donation After Circulatory Determination of Death (uDCDD): A Potential Solution to the Shortage of Organs in Quebec?
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016



Primary Outcome Measures :
  1. Potential contribution of a uDCDD program on the number of additional donors. [ Time Frame: 1 year ]

    Defined as (must meet all criteria):

    • Age ≤70 years old
    • Absence of obvious cause of death (rigor mortis, decapitation, overwhelming traumatic injury)
    • Absence of surgical cause of cardiac arrest
    • No sign of IV drug abuse
    • No history of malignancies


Secondary Outcome Measures :
  1. Effect of the implementation of a uDCDD program on the number of additional organs suitable for transplantation. [ Time Frame: 1 year ]
    Effect of the implementation of a uDCDD program on the number of additional organs suitable for transplantation.

  2. Number of tissus donors [ Time Frame: 1 year ]
    Number of tissus donors

  3. Potential obstacles and solutions related to the implementation of a uDCDD program in Canada. [ Time Frame: 1 year ]
    Potential obstacles and solutions related to the implementation of a uDCDD program in Canada.

  4. Areas of future research. [ Time Frame: 1 year ]
    Areas of future research.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted in one organ-donation center in Quebec that is a teaching hospital and referral center for interventional cardiology. It serves a mixed urban and rural population of 350,000.
Criteria

Inclusion Criteria:

  • All patients treated for cardiocirculatory arrest at the CIUSSS-Estrie CHUS in 2015.

Exclusion Criteria:

  • Patients with a status of no resuscitation
  • Pediatric patients (<18 years old)
  • Adults >65 years old

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): NCT03935230


Sponsors and Collaborators
Université de Sherbrooke
Investigators
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Principal Investigator: Frédérick D'Aragon, Dr/Pr Université de Sherbrooke
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Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT03935230    
Other Study ID Numbers: 2016-1416
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Université de Sherbrooke:
unexpected cardiopulmonary arrest
potential organ donors
Additional relevant MeSH terms:
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Death
Pathologic Processes