| Condition or disease |
|---|
| Uncontrolled Donation After Circulatory Determination of Death |
| 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 |
Defined as (must meet all 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 |
Inclusion Criteria:
Exclusion Criteria:
| 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 |
Potential contribution of a uDCDD program on the number of additional donors. [ Time Frame: 1 year ] Defined as (must meet all criteria):
|
|||
| Original Primary Outcome Measures | Same as current | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures |
|
|||
| 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 |
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:
Exclusion Criteria:
|
|||
| Sex/Gender |
|
|||
| 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 |
|
|||
| Responsible Party | Université de Sherbrooke | |||
| Study Sponsor | Université de Sherbrooke | |||
| Collaborators | Not Provided | |||
| Investigators |
|
|||
| PRS Account | Université de Sherbrooke | |||
| Verification Date | June 2016 | |||