Clinical trial NCT03935230: Uncontrolled Donation After Circulatory Determination of Death (uDCDD)
Official title: Uncontrolled Donation After Circulatory Determination of Death (uDCDD): A Potential Solution to the Shortage of Organs in Quebec?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uncontrolled Donation After Circulatory Determination of Death
Keywords: unexpected cardiopulmonary arrest
potential organ donors
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 1111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Potential contribution of a uDCDD program on the number of additional donors.
timeFrame: 1 year
Secondary outcomes:
measure: Effect of the implementation of a uDCDD program on the number of additional organs suitable for transplantation.
timeFrame: 1 year
measure: Number of tissus donors
timeFrame: 1 year
measure: Potential obstacles and solutions related to the implementation of a uDCDD program in Canada.
timeFrame: 1 year
measure: Areas of future research.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Université de Sherbrooke
name: Frédérick D'Aragon, Dr/Pr
role: PRINCIPAL_INVESTIGATOR
References: