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.
Donation after cardiac death (DCD) is a method by which patients have the opportunity to
donate organs following elective withdrawal of life-sustaining therapies (WLST). Often these
patients have suffered a catastrophic neurological injury although not progressed to brain
death or have a severe medical condition for which ongoing medical care is considered
non-beneficial. DCD has become an increasingly significant source of organs for
transplantation in a time of growing wait lists and organ shortfall.
In order to donate organs through DCD, the potential donor must progress to death within a
certain time window after withdrawal of life sustaining therapies. This timeframe varied but
is usually less than 120 minutes following WLST. Up to 40% of potentially eligible DCD
donors in Ontario do not proceed to organ procurement for these reasons (internal data from
Trillium Gift of Life).
The uncertainty and variability in the potential for successful organ procurement has an
impact on families, health care teams and organ retrieval teams. It is important that this
emotional and resource burden only occurs in candidates with a reasonable likelihood of
being eligible to donate organs. The amount of time elapsing between WLST and circulatory
arrest (and organ procurement) has important implications for the quality of the procured
organs, and some organs are unable to be transplanted after death. Finally, maintaining
organ procurement teams and an operating room on standby consumes valuable hospital
resources and removes these human and physical resources from other clinical duties.
Several different prediction tools have been proposed to predict time to death following
WLST in potential DCD donors, but none has been proven useful. To derive a more
generalizable prediction tool it is necessary to identify valid predictors that are common
to a wide variety of patients undergoing WLST. We propose the addition of features that
predict apnea or respiratory insufficiency in the development of a new predictive model.
While previous studies propose important variables for prediction of time to death, we
hypothesize that features that are focused on apnea (neurologic and non-neurologic) will be
independently predictive of time of death following WLST.
Neurological predictors of apnea: The previous studies have consistently identified one or
two neurologic risk factors for apnea associated with time to death. These risk factors have
been evaluated in isolation and have never been rigorously studied in a broader population
or in combination. We wish to evaluate the following neurological risk factors for apnea
which have been previously found to be associated with time to death in certain studies:
Glasgow Coma Scale, absence of brain stem reflexes (corneal, pupil, cough, gag), and
controlled mode of mechanical ventilation.
Non-Neurological predictors of apnea: No studies to date have evaluated features focused on
non-neurologic causes of apnea. Given that neurologic predictors of apnea have been the one
consistent feature that has been identified across most studies, we hypothesize that
evaluating additional predictors of apnea beyond neurologic causes could similarly have an
association with time to death as they both result in profound hypoxia. While some
researchers have evaluated the contribution of BMI and weight, we hypothesize that the
addition of more definitive features of upper airway obstruction will strengthen the
performance of our prediction tool. Neck circumference, absence of endotracheal tube cuff
leak, fluid balance, and history of obstructive sleep apnea (OSA) are novel and could
improve the operating characteristics of prediction tools.
Neck circumference has been found to be associated with airway obstruction and has been
incorporated into numerous prediction tools for OSA. In a study evaluating prevalence and
predictors of upper airway obstruction following stroke, neck circumference was
independently associated with any upper airway obstruction that occurred 24 hours following
acute stroke. In a pooled analysis, the absence of cuff leak has been shown to be predictive
of post extubation stridor with 92% specificity, thus suggesting impending loss of airway
patency. Fluid balance has also been found to be associated with post extubation failure.
We 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.
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Observational Model: Cohort, Time Perspective: Prospective
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