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出境医 / 临床实验 / Uncontrolled Donation After Circulatory Determination of Death (uDCDD) (uDCDD)

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

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
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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
Arms and Interventions
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
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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
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Principal Investigator: Frédérick D'Aragon, Dr/Pr Université de Sherbrooke
Tracking Information
First Submitted Date April 16, 2019
First Posted Date May 2, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date May 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 29, 2019)
  • 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.
  • Number of tissus donors [ Time Frame: 1 year ]
    Number of tissus donors
  • 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.
  • Areas of future research. [ Time Frame: 1 year ]
    Areas of future research.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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?
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Uncontrolled Donation After Circulatory Determination of Death
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 29, 2019)
1111
Original Actual Enrollment Same as current
Actual Study Completion Date August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03935230
Other Study ID Numbers 2016-1416
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Université de Sherbrooke
Study Sponsor Université de Sherbrooke
Collaborators Not Provided
Investigators
Principal Investigator: Frédérick D'Aragon, Dr/Pr Université de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date June 2016