- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935230
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
Status
Completed
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):
|
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.
Sponsor
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.
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