deli verable 5 - europa
TRANSCRIPT
COOR
R
RENOR project
esults
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t 2009 11 03 –
s of su
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
DELI
rvey o
publi
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
VERA
on dec
ic cam
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
ABLE 5
ceased
mpaign
ative amon transplant
Other: (Sp
l 2 only)
Consu
5
d dona
ns
ng nationatation pecify)
ltation P
ation a
al
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and
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INTR
ACHI
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RENOR project
RODUCTION
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HODOLOGY
ULTS
1. DEAT
2. CONS
3. TRAN
4. HEAL
5. QUA
6. INITIA
CLUSIONS
ERENCES
EX I
Deliverable arisework of the Hensible of any use
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t 2009 11 03 –
ARGETS IN C
Y & COMPLI
TH DIAGNO
SENT
NSPLANT PR
LTH CARE P
LITY ASSUR
ATIVE TO R
es from the COealth Programme that may be m
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
LINICAL PRA
IANCE
SIS
ROGRAMS A
ROFESSION
RANCE PROG
AISE AWAR
OORENOR projeme. The sole rmade of the infor
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
ACTICE
AND THEIR
NAL TRAININ
GRAMS (QA
RENESS ON
ject which has responsibility lirmation contain
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
ORGANIZAT
NGS
APs)
ORGAN DO
received fundinies with the au
ned here.
ative amon transplant
Other: (Sp
l 2 only)
Consu
TIONAL ASP
NATION
ng from the Euruthor and the
ng nationatation pecify)
ltation P
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PECTS
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COOR
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neuro
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the th
incide
reliab
the e
clear
from
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comm
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ident
Coun
may
pract
RENOR project
RODUCTION
Organ do
ological crite
ntly affirmed
herapeutic p
A Europe
ence of chro
ble rules and
Determin
ethical princi
and scienti
potential d
ational prog
munication.
Potential
parable crite
A more co
tify current
ntries; these
be of help
tices in a rea
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t 2009 11 03 –
N
onation from
eria (Brain D
d as “the prio
potential of t
ean context
onic diseases
d procedures
nation of dea
ple of the de
fic concepts
onor identif
grams and t
deceased o
ria and indic
omprehensiv
rules and p
data constit
as a first fu
lly common
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
m deceased
Death, DBD)
ority source o
ransplantati
t of strict c
s and a short
for adequat
ath is the co
ead donor ru
s and criteri
fication to o
to the publi
rgan donatio
ators to perf
ve report on
procedures a
tute the mai
undamental
European fra
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
persons, a
or by circul
of organs an
on” (WHO M
cooperation
tage of orga
te managem
ornerstone f
ule. Social co
ia for death
organ allocat
ic knowledg
on should be
form adequa
n critical step
as well as t
n target of t
step on th
amework.
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
as a conseq
atory criteri
d as having a
Madrid Resol
among Co
ns for transp
ent of the do
for deceased
onsent to org
h diagnosis;
tion should b
e through a
e continuous
ate program
ps of the orga
the main di
this work pa
e way of a
ative amon transplant
Other: (Sp
l 2 only)
Consu
uence of de
a (cardiac de
a fundament
ution, 2010)
ountries to
plantation re
onation proc
d organ don
gan donation
transparent
be conveyed
ad hoc cam
sly monitore
s, interventio
an donation
ifferences a
ckage and it
steady imp
ng nationatation pecify)
ltation P
eath determ
eath, DCD)
tal role in ma
).
face the in
equests com
cess.
ation and re
n should be
procedures
d to profess
paigns and
ed in each Co
ons and supp
process is n
mong the E
ts related su
plementation
al
Public
3
mined by
has been
aximizing
ncreasing
mon and
espect of
based on
s starting
ionals by
targeted
ountry by
port.
eeded to
European
urvey and
n of best
COOR
ACHI
comp
regul
must
neuro
neces
etiop
on th
brain
deter
the b
“circu
mech
both
coded
defin
(i.e.
deran
“diffi
the i
neuro
homo
confo
deter
that
safety
physi
progr
from
treat
the e
dona
betw
for th
RENOR project
IEVABLE TA
The dete
pliance with
arly updated
be secure,
ological or s
ssary and i
pathogenesis
he irreversib
stem functio
rmined depe
body with d
ulatory” (car
hanical venti
donation af
d by the WH
Such crit
ed and cons
postanoxic
ngements (h
cult” clinical
mplementat
osurgical int
ogeneously
ounding fac
rmination by
such rules a
y and quality
icians perfor
ramme devo
death diagn
The adeq
ment of acu
ethical basis
te from eac
ween the qua
he intensive
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ARGETS IN
ermination o
a straightfo
d according
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mportant g
s may be, de
ble loss of ca
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ending on th
etection of
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lation). Such
fter brain de
HO in a well‐d
eria and th
sistent, with
lesion or ce
hypotension,
scenarios a
tion of new
terventions
in each Co
ctors, brains
y neurologica
are invariab
y is the defin
rming the br
oted to the p
nosis to the d
uacy and qu
te cerebral l
for the dona
ch potential
ality of care a
care unit , a
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
CLINICAL P
of death by
orward prot
to current
d understand
reach the de
oal (Gardine
eath depends
apacity for c
g the capaci
he clinical cir
belated, i.e
and respirat
h diagnostic p
eath (DBD) a
defined algor
e resulting
particular at
ervical spina
, hypotherm
nd worst‐cas
techniques
such as dec
ountry, met
stem reflexe
al criteria sh
ly observed
nition of the
rain death d
roper manag
donation of o
uality of patie
esions and t
ation and tra
donor's fam
and the spec
and the maxi
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
PRACTICE
neurologica
tocol, dully a
knowledge
dable, in spi
efinition of a
er, 2012). W
s on the tot
consciousnes
ity to breath
rcumstances
. rigor mort
tory arrest)
pathway tha
and donation
rithm of "crit
regulations
ttention to th
al cord lesio
mia etc.) or
ses of “cardi
s of circulato
compressive
thodology a
es, apnoea
hould be par
d (Wjidicks,
e level of exp
diagnosis; to
gement of al
organs and ti
ent care, bot
to the percep
ansplant pro
mily. Therefo
cific educatio
imum oppor
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
al criteria ha
and fully fo
and best pr
ite of differe
a concept of
Whatever t
al failure of
ss combined
he. The set o
s is “somatic
tis, or unam
and “neurol
t can lead to
n after circu
tical pathwa
and guideli
he confound
on) or linke
treatment (
ac” and “bra
ory and res
e craniectom
and clinical
test) that
t of the regu
2010). An e
perience and
this it shou
ll clinical and
issues.
th with respe
ption of fam
ogram and to
ore it is nec
on and exper
rtunity and im
ative amon transplant
Other: (Sp
l 2 only)
Consu
as to be asc
llowed (prot
ractices). The
ent diagnost
f "universal d
he method
the brain fu
d with the ir
of criteria by
” (Gardiner,
mbiguous sign
ogical” (brai
o organ dona
latory arrest
ys" (Doming
nes should
ing factors c
ed to uncon
drugs, hypo
ain” death, c
piratory sub
mies. An ach
criteria (et
represent
ulations or o
extremely im
d the profess
uld also matc
d procedural
ect to intern
ily and socie
o seek and o
essary to su
rtise of med
mproved abi
ng nationatation pecify)
ltation P
certained an
tocol which
e diagnosis
tic criteria, c
death" is the
and mecha
unctions and
rreversible lo
y which deat
2012) (insp
ns, i.e. deca
in‐injured su
ation conside
t (DCD) was
guez‐Gil, 201
be methodo
caused by th
ntrolled phy
othermia etc
can be also c
bstitution (E
hievable goa
tiology, excl
the basis o
official guide
mportant crit
sional qualifi
ch a specific
steps of the
ational guide
ety, should c
obtain the co
upport the c
ical teams, e
ility for a pre
al
Public
4
nd set in
shall be
of death
ardiac or
erefore a
anism of
is based
oss of all
th can be
ection of
apitation)
ubjects to
ering that
s recently
1).
ologically
e disease
siological
c.); today
caused by
CMO) or
al is that
usion of
of death
lines and
terion of
ication of
c training
e process,
elines for
onstitute
onsent to
close link
especially
ecise and
COOR
safe d
targe
maxim
unit a
case
relati
qualif
for a
exten
overa
RENOR project
determinatio
ets are, first
mum confide
The quali
are largely b
of a consen
ionship of tr
fied support
ll patients a
nd to the off
all quality of
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on of death
of all, the b
ence of fami
ty of family
bound to the
nt expressed
rust are una
t during the e
nd their fam
fer of donat
the care pro
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
in all the sub
est therapeu
lies and the
support and
e positive res
d in life, the
voidable ass
end of life p
milies, as we
ion with an
ocess (Bion e
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
bjects who m
utic results f
best functio
d the trust re
sponse to th
e correct inf
sumptions in
eriod in all p
ll as for the
improveme
et al., BJA, 20
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
may fulfill th
for patients
oning of orga
elationship w
he request o
formation, fa
n order to re
patients in th
personnel o
nt both in te
012).
ative amon transplant
Other: (Sp
l 2 only)
Consu
e clinical cri
with acute c
ns in case of
with the staff
f donation t
amily suppo
each the do
he ICU would
of the ICU. T
erms of num
ng nationatation pecify)
ltation P
teria. The ac
cerebral dam
f donation.
f of the inten
to the family
rt and the e
onation. In g
d lead a clea
The benefit
mbers of gift
al
Public
5
chievable
mage, the
nsive care
y. Even in
empathic
general, a
ar benefit
may also
t that the
COOR
MET
decea
decea
camp
from
differ
27 Eu
and 2
detai
three
other
remin
from
Scand
respo
the q
the c
and r
by M
UNM
with
Cypri
the th
RENOR project
HODOLOGY
The work
ased donatio
ased donati
paigns on or
deceased do
In order
rent questio
uropean Me
2 internatio
l:
All the cr
cardiac d
The orga
accredite
assurance
Public ca
donation
During th
e questionna
r European
nder were al
25 Europea
diatransplan
onses for No
questionnaire
ountries tha
All replie
requests for
alta, Austria
The assoc
M, NTB, PSCU
the only exc
ot organizat
hree questio
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Y AND COM
k package 5
on. The spec
on procedu
gan donatio
onor.
to perform
nnaires (see
mber States
nal organiza
ritical steps
eath assessm
anizational
ed to organ
e programm
ampaigns re
.
he month of
aires and sta
Competent
lso sent in or
n countries p
t was addr
orway only a
e even if it w
t are part of
s to the thr
clarification
and German
ciated partn
UH and POLT
ception of th
tion was shut
onnaire to al
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
MPLIANCE
5 (WP5) of
cific objective
res in parti
n and trans
a deep an
ANNEX I) w
s (10 consort
ations (i.e. E
related to th
ment to orga
aspects of
transplanta
es).
garding the
February 20
arted collect
Authorities
rder to solici
plus Norway
essed to th
nd not for th
was not invo
the organiza
ree question
s were sent
ny.
ers involved
TRANSPLANT
he Cypriot Pa
t down durin
l the project
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
the COORE
e of this wor
icipating cou
plantation a
nalysis on al
were agreed
tium countri
urotransplan
he procedur
an transplant
existing pr
ation, health
deceased o
011 the Italia
ting the rep
for organs.
it replies. By
y (see Table 1
he former C
he whole Sc
olved in the
ation.
nnaires were
during the v
in this work
T. They all re
araskevaidio
ng the mont
t consortia, a
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
ENOR projec
rk package w
untries and
and their imp
ll the aspec
by the conso
ies and 17 E
nt and Scan
res of deceas
tation).
rogrammes
hcare profes
organ donat
an National
lies from th
A specific
y February 20
1). Indeed th
Chairman, w
andia area, w
work packag
e checked fo
validation pe
k package w
eplied to the
n Surgical an
h of Decemb
and even if t
ative amon transplant
Other: (Sp
l 2 only)
Consu
ct was entir
was to perfo
to analyze
pact on the
ts of decea
ortium and c
European com
diatransplan
sed donation
(overview
sionals train
tion and the
Transplant C
e consortium
deadline wa
012 response
e questionna
who replied
whereas Eur
ge but finall
or consistenc
eriod. No cla
ere ABM, KS
three quest
nd Transplan
ber 2011 bef
he questionn
ng nationatation pecify)
ltation P
rely devoted
rm an analy
the nation
number of
ased donatio
circulated am
mpetent Au
nt). They an
n (from cere
of medical
ning, existin
eir impact o
Centre circu
m countries
as given and
es had been
aire original
officially gi
rotransplant
y could not
cy and comp
arifications w
ST, HNBTS, P
tionnaire in
nt Centre (PS
fore the circu
naire was se
al
Public
6
d to the
sis of the
al public
donation
on, three
mong the
thorities)
alysed in
ebral and
centres
g quality
on organ
lated the
and the
d several
received
ly sent to
iving the
received
reply for
pleteness
were sent
PSTC, FCI,
due time
STC). The
ulation of
ent to the
COOR
Cypri
send
count
numb
Denm
IT
CZEC
F
HU
LA
LI
R
LEGEND
quest
perso
Octob
proce
RENOR project
ot Compete
their reply, t
Collecting
tries that ori
ber of questi
mark replies
TALY – CNT IS
CH REPUBLIC –
FRANCE ‐ ABM
UNGARY ‐ HNB
ATVIA – PSCU
THUANIA ‐ NT
ROMANIA ‐ FC
DA:
Table 1: List
During th
tions were m
onal interpre
ber 2012 in
ess of deceas
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nt Authority
the Italian N
g replies fro
iginally did n
ionnaire circ
are missing.
SS SL
– KST P
M
BTS
UH
TB
CI
COOR
Othe
SCAN
NO R
t of answering
he elaboratio
misunderstoo
etation. The
order to pro
sed donation
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
for organs a
ational Tran
m 27 countr
not want to s
ulated amon
COU
LOVAK REPUBUNM
POLAND ‐POLTRANSPLA
AUSTRIA
BELGIUM
BULGARIA
ESTONIA
FINLAND
RENOR partner
r EU Member S
NDIATRANSPLAN
EPLIES
countries
on and analy
od by the re
COORENOR
oceed with a
n in each Eur
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
and several r
splant Cente
ries it turned
send their co
ng the Europ
UNTRIES INV
BLIC ‐
ANT
T
r
States
NT
ysis of data
espondents w
R consortium
a further val
ropean Mem
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
reminders w
er did not ge
d to be a ha
ontribution to
pean Membe
VOLVED
GERMANY
GREECE
IRELAND
LUXEMBOU
MALTA
THE NETHERLA
PORTUGA
collected th
who gave dif
m decided to
lidation of d
mber States.
ative amon transplant
Other: (Sp
l 2 only)
Consu
ere sent in o
t any feedba
ard work in
o this survey
er States. Fin
Y
RG
ANDS
L
he WP leade
fferent repli
o extend the
ata and a de
ng nationatation pecify)
ltation P
order to urge
ack.
particular w
y because of
nally, only Cy
SLOVENI
SPAIN
SWEDEN
UNITED KING
NORWA
CYPRUS
DENMAR
er realized th
es according
e work‐pack
eeper analys
al
Public
7
e them to
with some
the large
yprus and
IA
N
GDOM
AY
S
RK
hat some
g to their
age 5 till
sis of the
COOR
RESU
1
legisl
frame
The C
count
and l
partic
legisl
order
partic
DCD
these
heart
Slove
by ci
asses
devot
cond
speci
criter
curre
patho
irreve
to th
detai
"appa
both
that,
RENOR project
ULTS
1. DEATH D
The analy
ative aspec
ework to the
Cardiac D
COORENOR
tries DCD pr
legal framew
cularly true
ation only in
r to confirm
cularly releva
has been pe
e Netherland
t beating don
enia and Swe
rculatory cri
ssment of ca
Concernin
ted to the d
ition and the
fied by 8 co
ria for card
ent means
ophysiology
ersible anoxi
e criteria of
led descript
arent death
for cardiac
according to
DocumenVersion:
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DIAGNOSIS
ysis on decea
t. All the s
e confirmato
Death and DC
project has
rogram is al
work for de
for “uncon
n 16 out of
m the cardi
ant for tissue
erformed (i.e
d and Belgium
nation is not
eden. Only Sl
iteria are cu
rdiac death b
ng the poss
uration of th
e observatio
ountries and
iac death re
of artificia
and timing
ic brain injur
brain death
ion, despite
" and the p
and neurol
o the pathop
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
– WP5 Deceas
S
ased donatio
specific aspe
ry test perfo
CD
not investi
ready devel
ath declarat
trolled” car
the 27 Euro
ac death. C
e donation.
e. Austria, Be
m do not ha
t allowed in
ovenia decla
urrently in p
between sur
sibility of no
he "no‐touch
on of the dea
it also varie
equire impr
al support
needed to
ry (Gardiner
h, cardioresp
the widespr
possible auto
ogical criter
physiology, p
ting a Euroanizations
DeNAL
– level 1 y)
Con(scie
sed Donation
on performe
ects related
ormed, were
igated DCD
oped; actua
tion and tec
rdiac arrest.
opean count
Clinical crite
In 2011 (New
elgium, Fran
ve specific r
Bulgaria, Hu
ared that nat
reparation.
rveyed count
on‐heart be
h period" wi
ad donor ru
es from 5 m
rovement an
and cardio
occur with
et al., Mana
piratory ones
read traditio
o‐resuscitatio
ria, the critic
potentially m
opean initi for organ eliverable 5
APPROVED nfidential – level
ntific community
– D5
ed in the fram
d to death
taken into a
organ dona
al situation d
chnical and
The cardia
tries (61.5%)
eria and leg
wsletter Tran
ce, Italy, Net
ules regulati
ngary, Germ
tional guidel
Figure 1 sho
tries.
eating donat
th respect to
le. The “no t
inutes (5) to
nd standard
opulmonary
certainty a
ra et al., BJA
s are certain
n and the sp
on after the
cal point co
modified or d
ative amon transplant
Other: (Sp
l 2 only)
Consu
mework of W
diagnosis, f
account.
ation in deta
depends on
organization
c death dia
). A half of t
gal rules for
nsplant, 201
therlands, Sp
ing cardiac d
many, Greece
ines regulati
ows the vari
tion (DCD),
o the irrever
touch period
o 10 (1) and
dization, eve
resuscitati
nd in all ca
A, 2012). Para
nly less subje
pecific proce
e suspension
ncerns the "
delayed by a
ng nationatation pecify)
ltation P
WP5 started
from the re
ails; howeve
the “no‐tou
nal problem
agnosis is fr
these (8) us
r cardiac d
2) only in 7 c
pain and UK
death diagno
e, Lithuania,
ing death de
iability of cr
special inte
rsibility of th
d” was indic
d 20 minutes
en compared
on, based
ases a comp
adoxically, c
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CARE PRO
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6. Existing qua
COUNTRY
AUSTRIA
BELGIUM
BULGARIA
ESTONIA
FRANCE
GERMANY
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t 2009 11 03 –
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YES
YES
YES
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In Hungary
e most (15) c
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units in 12 c
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Common ccriteria for adonors’ sui
YES
YES
YES
YES
YES
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Public
25
potential
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s”, WHO,
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countries.
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the number
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Table 7. Regul
OUNTRY
ITALY
HUANIA
LOVAK PUBLIC
LGARIA
NITED NGDOM
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Standprocedrepo
potentbetweelocal co
N
Y
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Number of deaths in ICU
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number of d
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./
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YES
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YES
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YES
YES
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YES
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YES
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YES
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YES
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YES
YES
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approximate
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Numnon‐
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26
clinical assessing itability
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YES
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cy, Renal
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2008. Ava
2. Action
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3. Barber K,
records. B
4. Bernat JL,
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cal determina
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– WP5 Deceas
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n Intensive
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e paper of
ble from
29.pdf
7. Review.
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Date: Confidential –(partnership only
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COOR
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Drafting DStatus:
t 2009 11 03 –
Coordinatorga
nt Type: FIN
Date: Confidential –(partnership only
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