Tissue and Organ Procurement Clinical Trial
Donation after Cardiac Death (DCD) is an increasingly common mechanism through wish patients
can donate tissue and organs following death after withdrawal of life sustaining therapies
(WLST). Unfortunately many potential DCD donors are not ultimately able to donate and this
is a significant emotional and resource burden to families, healthcare workers and
hospitals. A tool that allows accurate prediction of time to death following WLST (and thus
the probability of successful donation) is urgently needed. Existing models have not been
useful due to the lack of generalizability. Additionally, existing models have not included
other important factors now recognized to be associated with time to death following WLST.
The investigators will conduct a prospective, observational cohort study of all patients
being considered for DCD in whom consent for donation is obtained to evaluate the
association between neurologic and non-neurologic risk factors for apnea, other clinically
important variables and time to death after WLST, and use these data to derive a
generalizable predictive model for the prediction of the time to death following WLST in
potential DCD donors.
Status | Not yet recruiting |
Enrollment | 158 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 80 Years |
Eligibility |
Inclusion Criteria: - Planned withdrawal of life sustaining therapy - Deemed eligible for DCD by Trillium Gift of Life - Signed consent for DCD following withdrawal of life sustaining therapy Exclusion Criteria: - Refusal to or withdrawal of consent to DCD - Patients in whom organs are deemed unsuitable for donation prior to withdrawal of life sustaining therapy |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | The Physicians' Services Incorporated Foundation, Trillium Gift of Life Network, Ontario |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Death (at 120 minutes) | The primary outcome is death within 120 minutes of WLST. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest). | 120 minutes following withdrawal of life sustaining therapy | No |
Secondary | Death (at 60 minutes) | Death within 60 minutes of WLST is a secondary outcome. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest). | 60 minutes following withdrawal of life sustaining therapy | No |
Secondary | Death (at 30 minutes) | Death within 30 minutes of WLST is a secondary outcome. Time to death is defined as the period from the initiation of withdrawal of life supportive therapies and the declaration of death (inclusive of waiting period following circulatory arrest). | 30 minutes following withdrawal of life sustaining therapy | No |
Secondary | Warm Ischemic Time | 120 minutes following withdrawal of life sustaining therapy | No | |
Secondary | Number and Type of Organs procured | 24 hours following withdrawal of life sustaining therapy | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05041023 -
Experience of Relatives and Intensive Care Units Caregivers of Controlled Donation After Circulatory Death
|
||
Terminated |
NCT02585921 -
Organ Donation Interventions Among High Students
|
N/A | |
Completed |
NCT02318849 -
Online Intervention for ANHPI College Students
|
N/A | |
Terminated |
NCT01214018 -
Evaluation of Post-traumatic Stress Among the Nearest Relatives of Brain-dead Organ Donors
|
N/A | |
Completed |
NCT01922310 -
Communication Regarding Organ and Tissue Donation in Intensive Care
|
N/A | |
Completed |
NCT01213069 -
Staff Opinions and Knowledge Concerning Organ and Tissue Harvesting: an Investigation Among the Patient Care Personnel in the South-Mediterranean Region of France
|
N/A | |
Completed |
NCT00870506 -
Community Trial to Enhance Organ Donation
|
N/A | |
Completed |
NCT04123275 -
Prediction on Time to Death in Potential Controlled Donation After Circulatory Death (cDCD) Donors (DCD III Study)
|
||
Completed |
NCT04131140 -
Organ Donation and End-of-life Decisions
|
||
Recruiting |
NCT03458052 -
Organ Donation Survey Among Health Care Professionals in Argentina
|
N/A | |
Completed |
NCT00810901 -
Intervention to Motivate Teens to be a Designated Organ Donor on Driver's License
|
N/A |