The presence of close family members of the patient, who are informed about the exclusion of reversible confounders (e.g. metabolic disturbances, hypothermia or intoxication) and are present at a part of the examinations that are necessary for theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ernstige irreversibele neurologische schade leidend tot hersendood
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The rate of consent or refusal for organ donation by close family members of a
potential brain death patient, who were present during brain death
determination.
Secondary outcome
Understanding of the concept of brain death by family members of patients with
severe irreversible neurological damage.
Background summary
While organs like kidneys, liver or lungs can be procured from a non-heart
beating organ donor and a kidney or a part of a liver can be donated by a
living donor, the heart can only be obtained from a brain death donor. Besides
that, a mechanical ventilated brain death donor with isolated brain damage is
the *ideal* multi-organ donor. Around 85% of the patients with a confirmed
diagnosis of brain death were admitted at the ICU after a traumatic brain
injury or a subarachnoid hemorrhage (SAH). However brain death is since 1970 an
increasingly rare outcome of this disorders in the Netherlands.
The Dutch Coordination Group Organ Donation (CGOD) stated that a transition to
a Active Donor Registration system (ADR) is an important step to increase the
absolute number of organ donations after death. This is probably too much based
on the presumption that a large and hitherto unused potential exists. Although
a beneficial effect of the ADR would be real in case of the non-heart-beating
donors, it is very unlikely that this would be the same for the heart-beating
donors. As a result of the significant decline in the number of road traffic
accidents (RTA) and RTA-related deaths due to traumatic brain injury (TBI)
since 1970 and the effectiveness of preventive measures resulting in a decline
in the incidence of SAH, like discouraging smoking and early detection of
hypertension, an increase of brain death organ donors is not expected. Looking
at incidence and especially mortality rates of TBI and SAH, an rough estimation
of the potential can be made. An important measure to increase the absolute
number of conducted organ donations from brain dead donors can result from a
decline in the number of family-refusals for organ donation. In the Dutch
Master plan organ donation report (2008) a refusal rate for non-registered
donors, a best estimate of 51-53% is described. The exact figure is however
unknown. How many potential organ donors, as a result of family refusal, will
not end as effectuated organ donors is unknown. It is however generally
determined that relatives play a central role in whether or not an
organdonation can be carried out. For family members the conformation of brain
death, and the question of organ donation are conceptual and emotional
inextricably linked with each other. Family members of patients *recognize*
death by the absence of medical intervention, which is confusing when a dead
patient is mechanically ventilated, medicaments are administered and his or her
heart is still beating. It appears to be especially difficult to understand the
difference of *spontaneous breathing* and 'to be mechanically ventilated'.
Existing breathing appears conceptual and emotional to be strongly associated
with *life*
Study objective
The presence of close family members of the patient, who are informed about the
exclusion of reversible confounders (e.g. metabolic disturbances, hypothermia
or intoxication) and are present at a part of the examinations that are
necessary for the determination of brain death, shall give a better
understanding of the concept of brain death and can possibly lead to a higher
consent rate for organ donation
Study design
A multi-centre intervention study. There is a mix of academic and larger
secondary hospitals.
Intervention
To offer family members the opportunity to experience and observe the
examinations that are essential for the determination of brain death (with
exception of the electroencephalography).
Study burden and risks
The risk and burden for the patient is nil. There are no additional interventon
for the study. The burden for the family seems larger because the family is
actively involved in the entire donation process, which ultimately, should
result in the determination of brain death. We hope that through this
participation the mourning process for the family for such a far-reaching event
will be better. So, the net burden for the family will eventually be lower.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
1. A suspicion of a brain death patient on a intensive care unit of one of the participating hospitals. (patient satifies the preliminary conditions of the brain death protocol. Glasgow coma scale of 3, more than 1 absent brainstem reflex and mechanical ventilation).
2.Qualifies for postmortal organ donation with respect to age and the medical condition
3. Direct relatives are present on the ICu (18 years or older)
Exclusion criteria
1. Patient does not satisfy the preliminary conditions as for postmortal hearbeating organ donation.
2. Refusal of the patient for organ donation as declared in the "Donorregister" by the patient
3. Insufficient understanding of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL26926.078.09 |
Other | TC-1887 |
OMON | NL-OMON21921 |