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

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Université de Sherbrooke

Investigators

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

More Information

• Responsible Party: Université de Sherbrooke
• ClinicalTrials.gov Identifier: NCT03935230
• Other Study ID Numbers: 2016-1416
• First Posted: May 2, 2019
• 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:

Death; Pathologic Processes