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

April 29, 2019 updated by: Université de Sherbrooke

Uncontrolled Donation After Circulatory Determination of Death (uDCDD): A Potential Solution to the Shortage of Organs in Quebec?

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

1111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
Number of tissus donors
Time Frame: 1 year
Number of tissus donors
1 year
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.
1 year
Areas of future research.
Time Frame: 1 year
Areas of future research.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frédérick D'Aragon, Dr/Pr, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (ACTUAL)

May 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uncontrolled Donation After Circulatory Determination of Death

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