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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03935230
Other study ID # 2016-1416
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2016
Est. completion date August 2016

Study information

Verified date June 2016
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1111
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Death
  • Uncontrolled Donation After Circulatory Determination of Death

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Outcome

Type Measure Description Time frame Safety issue
Primary Potential contribution of a uDCDD program on the number of additional donors. 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 Effect of the implementation of a uDCDD program on the number of additional organs suitable for transplantation. Effect of the implementation of a uDCDD program on the number of additional organs suitable for transplantation. 1 year
Secondary Number of tissus donors Number of tissus donors 1 year
Secondary Potential obstacles and solutions related to the implementation of a uDCDD program in Canada. Potential obstacles and solutions related to the implementation of a uDCDD program in Canada. 1 year
Secondary Areas of future research. Areas of future research. 1 year