Uncontrolled Donation After Circulatory Determination of DeathuDCDDNCT03935230
Uncontrolled Donation After Circulatory Determination of Death (uDCDD)
An observational study of Uncontrolled Donation After Circulatory Determination of Death, run by Université de Sherbrooke.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Uncontrolled Donation After Circulatory Determination of Death
- How many people
- 1,111 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients treated for cardiocirculatory arrest at the CIUSSS-Estrie CHUS in 2015.
Who cannot join
- Patients with a status of no resuscitation
- Pediatric patients (<18 years old)
- Adults >65 years old
About this study
Official title: 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.
Read the 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.
- Keywords
- unexpected cardiopulmonary arrest, potential organ donors
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
Number of tissus donors
Number of tissus donors
Measured: 1 year
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.
Measured: 1 year
Areas of future research.
Areas of future research.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study startMay 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled Donation After Circulatory Determination of DeathStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérick D'Aragon, Dr/Pr, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935230
- Sponsor's protocol ID
- 2016-1416
- Acronym
- uDCDD
- Status last verified
- Jun 2016
- First submitted
- 16 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Donation After Circulatory Determination of Death (uDCDD): A Potential Solution to the Shortage of Organs in Quebec?
- ClinicalTrials.gov ID
- NCT03935230
- Acronym / sponsor ID
- uDCDD / 2016-1416
- Keywords
- unexpected cardiopulmonary arrest, potential organ donors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients treated for cardiocirculatory arrest at the CIUSSS-Estrie CHUS in 2015.
Key exclusion criteria (3 listed)
- Patients with a status of no resuscitation
- Pediatric patients (<18 years old)
- Adults >65 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Effect of the implementation of a uDCDD program on the number of additional organs suitable for transplantation.
Time frame: 1 year
Number of tissus donors
Time frame: 1 year
Potential obstacles and solutions related to the implementation of a uDCDD program in Canada.
Time frame: 1 year
Areas of future research.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédérick D'Aragon, Dr/Pr principal investigator
Université de Sherbrooke
Questions about this trial
What is this clinical trial studying?
An observational study of Uncontrolled Donation After Circulatory Determination of Death, run by Université de Sherbrooke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential contribution of a uDCDD program on the number of additional donors. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.