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ICECAP project map

A graphical layout and flow of the strategy for designing a clinical trial of hypothermia after cardiac arrest
by

Robert Silbergleit

on 3 February 2017

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Transcript of ICECAP project map

Onset of cooling
How do we make cooling work better?
ROC effort
NETT effort
Collaborative effort
Depth of cooling
Rapidity of cooling
Method of cooling
Duration of cooling
Protocol Final Design
Leadership
Outcomes
Clinical
Standardization

EMS
Statistical and
Data Management

Safety and
AE Reporting

Institute pre-approval
Grant submission
Peer review and
Revision

Ancillary studies
DO THE
TRIAL !!!

Tulsky
Caveney
Carlozzi
Victorson
Geocadin
mRS
local or central?
modifications of training?
at what time points?
patient report outcomes (domains and tools?)
NeuroQoL- PROMIS
NIH Toolbox
Conventional?
at what time points?
neuropsych
(domains and tools?)
memory plus....?
Cogstate, IMPACT, others...
NIH Toolbox
avoid pen and paper
at what time points?
single computer platform?
total test battery length?
Aufderheide
Swor
McMullen
Sasson
Vonderschmidt
Haukoos
LINK TO ADAPT-IT Working Group Notes

https://docs.google.com/document/d/1n1tj2RVbAwfuOpQ9EQdHw71fSa9figXTZvyvXe3gGQo/edit
Data collection
rhythm strips
witnessed?
time points
capnography
CPR data
bystander
Subjects only or on others as well?
Associate with registry? How?
Peer-to-peer support for prehospital cooling
O'Neil
Vanden Hoek
Neumar
Wijman
Sawyer
Tulsky
Geocadin
Rittenberger
imaging and prognosis
biomarker and prognosis
electrophysiology and prognosis
cEEG and management
biomarkers and mechanisms
detailed assessment of scores
serial neuropsych
validation of AHA initiative for novel outcome measure
Geocadin
Mayer
Knight
O'Neil
Ornato
Wright (advisor)
Other specialty reps
Nurse
Identify transgressions to track
Negotiate/promote guidelines
blood pressure
oxygenation
ventilator management
post rewarming temperature
shivering control
sedation and paralysis
early termination (malignant profile)
other prognostic testing
treatment of seizures
temperature measurement
treatment of infections
PCI
Link to ICECAP Final ADAPT-IT presentation
https://docs.google.com/open?id=0B_H16DRpTn90dEU3dzdMVk9ibFE
Tom Aufderheide
Bill Barsan
Scott Berry
Brian O’Neil
Cliff Callaway
Angi Caveney
Valerie Durkalski
Jordan Elm
Romer Geocadin
Carmelo Graffagnino*
Todd Graves
Elizabeth Jones*
William Knight*
Roger Lewis
Robert Lowe
Stephan Mayer
Jason McMullan
Will Meurer
Bob Neumar
Joseph Ornato
Art Pancioli
Ramesh Ramakrishnan
Comilla Sasson
Kelly Sawyer
Phillip Scott
Robert Silbergleit
Robert Swor
David Tulsky*
Terry Vanden Hoek
Kay Vonderschmidt
Christine Wijman
(*unable to attend 4/30 meeting)
Durkaski
Ramakrishnan
Elm
Berry
Graves
Statistical analysis plan
Implementation of RAR
Simulations needed
Details of parallel strata
Identify and define key SAE
pneumonia
UTI
other infections
arrhythmia
seizures
electrolyte abnormalities
DVT
coagulopathies
distinguish SAE & transgression
identify external med monitor
Action items
create a first draft based on NY guideline and then route to the group. (Brian and Romer) then Stephan then Bill then Kelly then Robert by July 15, then reconference.

reach out to other critical care communities (look for representatives from medical and cardiac critical care communities). Dave Seder? (Stephan will ask)

collate existing protocols. Robert and reschedule next meeting.
Notes:
Source documents reasonably available include...
paper code summary maybe, but not electronic?

Time points: call time, EMS on scene, shocks, ED arrival.
Not practical CPR time, ROSC time,

Bystander yes/no, AED yes/no, witnessed yes/no,
Capnography (if available) to give objective ROSC time?

What is the screening log denominator? all codes transported to an enrolling hospital.

CPR quality data important but unlikely to be available?

Try to coordinate with CARES definitions. Is there
Identify non-NETT sites
(obtain background data
and letters of intent)
University of Colorado
University of Alabama
University of Illinois
Duke?
Notes from 2/4 call
https://docs.google.com/document/d/1ZMJwRWi7LP4DRGYDGheQc-ox8aCR-7y8Zc84Q30m1lA/edit?usp=sharing
IDE application to FDA
approved
Full transcript