Embed Size (px)
Citation preview
International Trauma Research Network (INTRN)
PPhhiill SSppiinneellllaa St Louis
CLINICAL TRAUMA RESEARCH
‘Noisy’
Volume
Time
Quality
Diversity
TWO MODELS
Network Formali�es Topic Studies
Topic Formali�es Trial Partners
The Interna�onal Trauma Research Network (INTRN) was formalised in 2010 INTRN is a collabora�on of academic trauma centres aiming to: maximise the capacity and capability for research in trauma sciences accelerate transla�on of research into evidence-‐based prac�ce, into policy
deliver a coordinated and harmonised approach to an impac�ul por�olio
support the development of researchers in trauma sciences
promote intra-‐ and inter-‐disciplinary sharing of ideas
enable effec�ve dissemina�on of its results
INTRN – what does it want to do?
STUDY PROTOCOL ACIT III
Thromboelastography in Trauma Haemorrhage (TEGinTH)
TEGinTH study -‐ 900 pa�ents (2yrs)
$1M funding for INTRN -‐ AMC, OSL, QM (CPH, COL)
Another VHA technique? -‐ Sensi�vity & specificity of TEG assays versus established laboratory measures
Challenges
3
11
5
12
17
13 13
9
0
6
5
9
11
7
8
7
5
3
6
2
5
6
3 3 3
2
4
5
3
1
2
6
4
0 0
3
4
15 20
32
49
62
75 84 84
90 95
104
115 122
130 137
142 145 151 153
158 164 167 170 173 175
179 184 187 188 190
196 200 200 200 203
0
2
4
6
8
10
12
14
16
18
0
50
100
150
200
250
Wee
k 5
Wee
k 6
Wee
k 7
Wee
k 8
Wee
k 9
Wee
k 10
W
eek
11
Wee
k 12
W
eek
13
Wee
k 14
W
eek
15
Wee
k 16
W
eek
17
Wee
k 18
W
eek
19
Wee
k 20
W
eek
21
Wee
k 22
W
eek
23
Wee
k 24
W
eek
25
Wee
k 26
W
eek
27
Wee
k 28
W
eek
29
Wee
k 30
W
eek
31
Wee
k 32
W
eek
33
Wee
k 34
W
eek
35
Wee
k 36
W
eek
37
Wee
k 38
W
eek
39
Wee
k 40
TEG in Trauma Recruitment Oslo
Recruitment per week
Cummula�ve total
STRUCTURE
ToR
Chair
Communication
Members
Manager
CHALLENGES
Differences
Logistics
Study personnel
Funding
Data protection
Ethics
COLLECTION, PROCESSING, TRANSFER AND ANALYSIS OF STUDY MATERIALS
Pa�ent Data
Tissue Local Stores Centralised
Repositories MTA
DUA
INTRN TOR
3rd Party Contracts
CA CA
CA CA
CA
MA
Sponsors
”When using standard laboratory tests of coagulation, ATC should be defined as an admission PTr > 1.2”
£38K funding from NHS BT -‐ Trials Coordinator at QMUL
● Feasibility study -‐ Mul�centre, RCT evalua�ng the effects of early administra�on of cryoprecipitate in major trauma�c haemorrhage
TACTIC: An INTRN initiative
Targeted Action for Curing Trauma Induced Coagulopathy (TACTIC)
€5.88m European Union Framework Programme 7 (FP7) Health
Star�ng in Nov’13, INTRN will con�nue to work alongside the key industry leads in coagula�on diagnos�cs for this 5-‐year programme to:
1. Compare coagula�on & outcomes in response to different exis�ng transfusion strategies
2. Specify different disease profiles underlying Trauma Induced Coagulopathy
3. Develop personalised strategies for targeted transfusion
4. Compare exis�ng prac�ces with personalised, targeted treatment of coagulopathy
5. Deliver guidelines and support for the clinical management of coagulopathic bleeding
Platelet function Clot strength (G)
Predict massive transfusion ?
Crit Care Med. 2011
?
TACTIC The TACTIC research program and work packages (WP) revolves around:
1. An observa�onal study of approximately 2.000 trauma
pa�ents with blood samples, func�onal haemosta�c & clinical data already completed before TACTIC commence (WP3-‐6)
2. A randomized controlled trial where 1.800 trauma pa�ents are screened and 400 randomized to goal-‐directed interven�ons based on TEG/TOTEM vs. standard therapy (WP7-‐9)
PRACTICE
TRAUMA PATIENT DATA & TISSUES
[WP2]
MOLECULAR PATHOPHYSIOLOGY
[WP4]
DIAGNOSIS [WP5]
EXISTING TREATMENT [WP3]
FUNCTIONAL COAGULATION RESPONSE TO TREATMENT
[WP6]
TREATMENT ALGORITHM
[WP6]
CLINICAL DECISION SUPPORT [WP7]
RANDOMISED CONTROL TRIAL [WP8]
DISSEMINATION [WP9]
PROGRA
MME CO
ORD
INNAT
ION
[WP1
] 60
mon
ths
HEALTH ECONOMICS
POLICY
IMPACT
TACTIC work packages & timelines
TACTIC Partners
