Back to resultsA Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2) (iCOOL 2)
Primary Purpose
Ischemic Stroke, Hemorrhagic Stroke
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
EMCOOLS Flex.Pads
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring hypothermia, induction of hypothermia, cold infusion, whole-body cooling, external cooling, surface cooling, non invasive cooling, stroke, intracranial hemorrhage, cerebrovascular disease, neuro intensive care
Eligibility Criteria
Inclusion Criteria:
- Sedation
- Combined ICP-temperature-probe
- Indication to lower body temperature > 1.5°C
- Age ≥ 18 years
Exclusion Criteria:
- Body weight > 120 kg
- Severe renal insufficiency
- Acute pulmonary embolism
- Acute myocardial infarction
- High-grade heart valve stenosis or insufficiency
- Severe cardiac insufficiency (NYHA ≥ III)
- Threatening ventricular dysrhythmia
- Cardiac dysrhythmia with bradycardia (heart rate < 45 /min, QTc > 450 ms, sick sinus syndrome, AV-block II-III°).
- Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
- Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
- Skin lesions not allowing a secure application of the EMCOOLS Flex.Pads
Sites / Locations
- Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital HeidelbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Cold infusions
EMCOOLS Flex.Pads
Arm Description
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria)
Outcomes
Primary Outcome Measures
Brain temperature
Primary endpoint: Change of brain temperature during one hour after start of cooling. Repeated measurement ANOVA for within subject contrasts (phase 1 (0 to 15min), 2 (15 to 30min), 3 (30 to 45min) and 4 (45 to 60min)) vs. baseline (-15 to 0min)
Secondary Outcome Measures
(Neuro-)vital parameters
Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered
Cerebral autoregulation
Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
Safety
Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.
Full Information
NCT ID
NCT01584167
First Posted
April 21, 2012
Last Updated
June 21, 2013
Sponsor
University Hospital Heidelberg
1. Study Identification
Unique Protocol Identification Number
NCT01584167
Brief Title
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2)
Acronym
iCOOL 2
Official Title
iCOOL 2 (Induction of COOLing 2): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Heidelberg
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mild hypothermia improves outcome in patients with global cerebral ischemia after cardiac arrest. Hypothermia seems promising also in other acute hypoxic-ischemic or in brain swelling associated cerebrovascular disease. The narrow-time-frame is a major issue ("time is brain"). To provide immediate cooling without delay, easy to use, mobile and effective methods are needed. Cold infusions (4 °C) are an accepted standard worldwide. EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) is a new non-invasive surface cooling system. A comparison of these two induction methods has never been done before. Neither was the effect of EMCOOLS Flex.Pads on brain-temperature measured. For the first time iCOOL 2 compares feasibility, safety and efficacy of the two methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hemorrhagic Stroke
Keywords
hypothermia, induction of hypothermia, cold infusion, whole-body cooling, external cooling, surface cooling, non invasive cooling, stroke, intracranial hemorrhage, cerebrovascular disease, neuro intensive care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cold infusions
Arm Type
Active Comparator
Arm Description
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Arm Title
EMCOOLS Flex.Pads
Arm Type
Active Comparator
Arm Description
Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria)
Intervention Type
Drug
Intervention Name(s)
Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Intervention Description
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Intervention Type
Device
Intervention Name(s)
EMCOOLS Flex.Pads
Other Intervention Name(s)
Emergency Medical Cooling Systems AG, Wien, Austria
Intervention Description
Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
Primary Outcome Measure Information:
Title
Brain temperature
Description
Primary endpoint: Change of brain temperature during one hour after start of cooling. Repeated measurement ANOVA for within subject contrasts (phase 1 (0 to 15min), 2 (15 to 30min), 3 (30 to 45min) and 4 (45 to 60min)) vs. baseline (-15 to 0min)
Time Frame
-15 to +60min
Secondary Outcome Measure Information:
Title
(Neuro-)vital parameters
Description
Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered
Time Frame
-15 to +180 min
Title
Cerebral autoregulation
Description
Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
Time Frame
15 to +180 min
Title
Safety
Description
Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.
Time Frame
0 - 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sedation
Combined ICP-temperature-probe
Indication to lower body temperature > 1.5°C
Age ≥ 18 years
Exclusion Criteria:
Body weight > 120 kg
Severe renal insufficiency
Acute pulmonary embolism
Acute myocardial infarction
High-grade heart valve stenosis or insufficiency
Severe cardiac insufficiency (NYHA ≥ III)
Threatening ventricular dysrhythmia
Cardiac dysrhythmia with bradycardia (heart rate < 45 /min, QTc > 450 ms, sick sinus syndrome, AV-block II-III°).
Known hematologic disease with increased risk of thrombosis (e.g. cryoglobulinemia, cold agglutinins, sickle cell anemia)
Known vasospastic vascular disorder (e.g. Raynaud's phenomenon or thromboangiitis obliterans)
Skin lesions not allowing a secure application of the EMCOOLS Flex.Pads
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sven Poli, Dr. med.
Phone
0049 6221 56
Ext
0
Email
sven.poli@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Poli, Dr. med.
First Name & Middle Initial & Last Name & Degree
Jan C Purrucker, Dr. med.
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2)
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