Download - Brain Injury Outcomes

CLEAR-III
CT Radiology Course
Hemorrhage Surveillance &
Protocol Decision Making Using CT
Objectives
•
•
•
•
Imaging studies by protocol
CT based protocol decisions
Taking Stability Measurements
Example Subjects
– Checking for recurrent hemorrhage
– Checking for stability
CLEAR III Clinical Protocol
CT Based Decision Making
Dx CT 
ICH/IVH
Stability
Determination
EVD
Consent &
Enrollment
Test Article q8hr
* Investigator may modify CT timing
based on expected endpoint
E
V
D
Dosing
CT scan
Day
1
2
3
4
5
24hrs post
last dose
= Diagnostic
= Stability
6
7
30
72hrs post
last dose
= Daily PI Review
365
Making Protocol Decisions
Based on CT
Outdated Clinical Definition
of Rebleeding
• “Rebleed”
– A patient with a known hemorrhage
deteriorates and has a CT scan. The scan
shows more blood.
** This is the old, "clinical” definition
pre Novo 7 trial
CLEAR III Trial:
Definition of Recurrent Hemorrhage
• Stability of ICH, IVH, and catheter tract is
determined.
– Requires comparing CTdiag and CTstability
• On a 3rd Scan, any new or enlarged ICH,
IVH or catheter tract bleed is a recurrent
hemorrhage.
Primary IVH:
Cessation of bleeding may be hard to define
• Q: “Is IVH without ICH a predisposing
condition to ongoing bleeding?”
A: Possibly …
• Why might this be?
– no back pressure to bleeding
– 1˚ IVH may continue to enlarge longer than ICH (i.e. 12 vs. 3
hours), ref Brott & Broderick.
Recurrent Hemorrhage
Day 4
Day 5
Catheter Tract Hemorrhage Example
Petechial
< 5 mm
Day 7 post
IVC insertion
Confluent without
local mass effect
<5 mm
Day 8 post
IVC insertion
Confluent with
local mass effect
>5 mm
Day 13 post
IVC insertion
Catheter Tract Hemorrhage
Stabilization Algorithm
Is there a new
catheter
hemorrhage?
No
Continue
Treatment on
Regular
Schedule
Yes
What kind of
Hemorrhage
< 5 ml, or < 5
mm in largest
diameter
Continue Regular
Dosing and CT
Schedule
> 5 ml, or > 5 mm in
largest diameter, with or
without local mass effect
Hold next dose and
obtain a CT scan 12
hours after previous
scan.
Did the hemorrhage
enlarge on the follow-up
scan?
No
Continue
Treatment on
Regular
Schedule
Yes
Discontinue
Injections and
get another CT
12 hours later
When to hold drug?
Answer : Evidence of Recurrent Bleeding
• Catheter tract expands by > 5 ml, or
> 5 mm linear diameter
• ICH expands by 5 ml
• IVH diameter expands by 2 mm in
multiple locations
When to Stop Drug?
Answer : Treatment Success Endpoints
• Clearance of the IIIrd and IVth ventricles
• 80 % clot reduction
• Relief of mass effect
Clearance of IIIrd & IVth
Pre-dosing
Post Treatment
Relief of Lateral Shift
Pre-dosing
Post-treatment
Methods for Assessing
Hemorrhage Change
ABC/2 (ICH)
Ventricular Clot Measurements (IVH)
Modified GRAEB Score (IVH)
Measure ICH Volume:
ABC/2 Method
1.
Choose the slice for the A and B measurements.
2.
Measure the longest diameter possible. This is
your A measurement.
3.
Measure the longest remaining diameter that is
perpendicular to your A measurement line. This
is your B measurement.
4.
Beginning at the base slice, count the number of
slices in which the ICH is visible. Multiply this
number by the slice thickness in centimeters.
This is your C measurement.
5.
Multiply A x B x C, and then divide the product
by 2. This is your ICH volume in mL (cc).
A
A’
Measure IVH: Lateral Ventricle
Clot Measures
• Measure width of clot in most involved
ventricle at anterior, middle, and posterior
regions on a single CT slice
• Keep measurement location consistent
across daily CT scans to make comparisons
• Increase in 2 or more locations by ≥ 2mm
is significant and stability should be reconfirmed before continuing rt-PA.
Diagnostic CT
Stability CT
Timeline
Example Subject 1
Ex. Subject 1
Pre-rebleed
Ex. Subject 1
04/29/2001
04/30/2001
before
after
Post-rebleed
04/30/2001
Category: recurrent IVH +
new cath. tract
Example Subject 2
Timeline
Clot Volume vs. Time from Stability
Clot Volume [cc]/ Graeb Score
40
35
30
ICH
Right Lat
Left Lat
3rd
4th
Catheter Tract
25
20
15
10
5
0
-5
0
5
10
15
20
Elapsed Time from Baseline Stability [hrs]
Ex. Subject 2
Diagnostic
CT
May 25th at 12:19
Purpose: Identify
patient as CLEAR
III candidate
Ex. Subject 2
Stability CT
#1
May 25th at 21:31
(IVC #1 placed 5/25/10 at 14:45)
Purpose: Check
placement of IVC
(SOC)
Ex. Subject 2
Diagnostic (5/25/10 12:19)
Stability CT #1 (5/25/10 21:31)
Anterior: 16.59mm
Posterior: 17.93mm
ICH ABC/2: 9.49cc
Anterior: 18.94mm
Posterior: 26.23mm
ICH ABC/2: 32.10cc
Ex. Subject 2
Stability CT
#2
May 26th at 09:44
Purpose: Confirm
stability
•
IVH
•
ICH
•
Catheter Tract
Ex. Subject 2
Stability CT #1 (5/25/10 21:31)
Stability CT #2 (5/26/10 09:44)
Anterior: 18.94mm
Posterior: 26.23mm
ICH ABC/2: 32.10cc
Anterior: 17.00mm
Posterior: 23.22mm
ICH ABC/2: 29.46cc
Ex. Subject 2
Stability CT
#3
May 26th at 17:32
(IVC #2 placed 5/26/10 at 11:19)
Purpose: Confirm
Stability after
new IVC
placement
Repeat CT >12hrs Later to Confirm Stability
Stability CT #3 (5/26/10 17:32)
Stability CT #2 (5/26/10 09:44)
Anterior: 17.00mm
Posterior: 23.22mm
ICH ABC/2: 29.46cc
Anterior: 17.42mm
Posterior: 24.92mm
ICH ABC/2: 23.92cc
Catheter Tract: 13.30mm
Ex. Subject 2
Stability CT
#4
May 27th at 05:30
Purpose: Confirm
Catheter Tract
Stability
Repeat CT >12hrs Later to Confirm Stability
Stability CT #3 (5/26/10 17:32)
Stability CT #4 (5/27/10 05:30)
Anterior: 17.42mm
Posterior: 24.92mm
ICH ABC/2: 23.92cc
Catheter Tract: 13.30mm
Anterior: 17.16mm
Posterior: 25.53mm
ICH ABC/2: 26.92cc
Catheter Tract: 12.28mm
Lesson
• Measure the ventricle diameter accurately in 3 locations
to check of IVH stability.
• Use ABC/2 to check ICH stability.
• Check for catheter tract hemorrhage with insertion and
manipulation of all catheters.
• If any of these locations show increased bleeding, wait
and get another CT before randomizing the patient.
* Do not enroll an unstable patient
• Don’t give up!
What to take home?
• Always compare two CT’s.
• Look for signs of NEW or EXPANDING: ICH,
IVH, Catheter tract blood.
• When comparing new to old scan always ask can
we stop drug now?
– i.e. Is the 3rd and 4th open? Is the lateral shift gone? Has 80%
reduction been achieved? (Therefore, I can consider stopping
drug now.)