ZOLL Thermogard XP IVTM System Operation Manual - Manual (Page 23)

Introduction
1
Indications for Use - USA
The Indications for Use listed below have clearance within the USA for the
following models of ZOLL Thermal Regulation System:
 The CoolGard 3000
 The Thermogard XP
These systems can be used with any of the Alsius Catheters. The indications for
use are specific to the catheter. Please refer to the Indications for Use statement
in the catheter specific Instructions for Use.
Indications for Use – Cool Line Catheters
The ZOLL Thermal Regulation System using the Alsius Cool Line™ Catheter is
indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in
patients with cerebral infarction and intracerebral hemorrhage who require
access to the central venous circulation and who are intubated and sedated.
Warning – Fever Reduction
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 random-
ized 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).
Table 1-1. Mortality by Diagnosis (ITT).
Cool Line Control
n N % n N % p-value*
CI 3 16 18.8 3 14 21.4 0.74
ICH 8 33 24.2 7 27 25.9 1.00
PTBI 10 44 22.7 4 38 10.5 0.24
SAH 13 61 21.3 7 63 11.1 0.15
*Fischer’s exact test
For more details on the results of this study please refer to Physician’s Manual –
“Normothermia for the Neuro-critically Ill Stroke Patient” #101416-001.
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