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ZOLL IVTM™ System
The safety of this device has not been demonstrated for fever reduction in patients
presenting with subarachnoid hemorrhage or primary traumatic brain injury. The
safety and effectiveness of this device was examined in a randomized controlled trial
of 296 patients. The mortality results reported in this trial, for the four patient cohorts
enrolled, are presented in the table below (CI – cerebral infarction, ICH –
intracerebral hemorrhage, PTBI – primary traumatic brain injury, SAH – subarachnoid
hemorrhage).
n
CI
3
ICH
8
PTBI
10
SAH
13
*Fischer's exact test
Clinical Study Results in Detail
Significant Reduction in Fever Burden
The table below, Reduction in Fever Burden, provides the results of the study in
terms of its primary end-point for all patients using an intention to treat analysis.
There was an highly significant reduction in the fever burden when comparing the
use of the IVTM System with the standard methods of fever management.
Cool Line
N
154
Mean
1.42
95% CI
1.19 – 1.52
p-value
This result was obtained with a significant reduction in the use of topical cooling
devices and antipyretic medication use. These results in the following two tables.
The two graphs below present the mean temperatures, left justified over the study
period, for all patients within the Cool Line and Control cohorts.
600248-001 Rev 3
Table 2. Mortality by Diagnosis (ITT)
Cool Line
N
%
16
18.8
33
24.2
44
22.7
61
21.3
Table 3. Fever Burden – ITT Data Set
Log Scale
Control
142
2.23
2.06 – 2.41
<0.0001
15
Control
n
N
3
14
7
27
4
38
7
63
Natural Scale
Cool Line
Control
154
142
2.87
7.92
2.27 – 3.58
6.82 – 10.09
Physicians' Manual
%
p-value*
21.4
0.74
25.9
1.00
10.5
0.24
11.1
0.15
% Reduction
64%
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