- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01584167
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2) (iCOOL 2)
June 21, 2013 updated by: Dr. Sven Poli, University Hospital Heidelberg
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sven Poli, Dr. med.
- Phone Number: 0049 6221 56
- Email: sven.poli@med.uni-heidelberg.de
Study Locations
-
-
-
Heidelberg, Germany, 69120
- Recruiting
- Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
-
Principal Investigator:
- Sven Poli, Dr. med.
-
Sub-Investigator:
- Jan C Purrucker, Dr. med.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cold infusions
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
|
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
|
Active Comparator: EMCOOLS Flex.Pads
Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria)
|
Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain temperature
Time Frame: -15 to +60min
|
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)
|
-15 to +60min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(Neuro-)vital parameters
Time Frame: -15 to +180 min
|
Effects on (neuro-)vital parameters (e.g.
HR, AP, ICP, CPP) are registered
|
-15 to +180 min
|
Cerebral autoregulation
Time Frame: 15 to +180 min
|
Cerebral auto-regulation parameters (e.g.
PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
|
15 to +180 min
|
Safety
Time Frame: 0 - 7 days
|
Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.
|
0 - 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sven Poli, Dr. med., University Hospital Heidelberg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
April 21, 2012
First Submitted That Met QC Criteria
April 21, 2012
First Posted (Estimate)
April 24, 2012
Study Record Updates
Last Update Posted (Estimate)
June 24, 2013
Last Update Submitted That Met QC Criteria
June 21, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- iCOOL 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemic Stroke
-
Nordsjaellands HospitalRigshospitalet, Denmark; Metropolitan University CollegeCompletedTransient Ischemic Attack | Stroke, Ischemic | Stroke HemorrhagicDenmark
-
University of CalgaryThe George Institute for Global Health, AustraliaNot yet recruitingAcute Ischemic Stroke AIS | Stroke, Acute, Stroke Ischemic | Stroke AcuteCanada, Australia
-
Second Affiliated Hospital, School of Medicine,...Shanghai Zhongshan Hospital; First Affiliated Hospital of Wenzhou Medical University and other collaboratorsRecruitingAcute Ischemic Stroke and Transient Ischemic AttacksChina
-
Medtronic Cardiac Rhythm and Heart FailureMedtronic Bakken Research CenterCompletedCryptogenic Symptomatic Transient Ischemic Attack | Cryptogenic Ischemic StrokeNetherlands, United States, France, Belgium, Germany, Sweden, Italy, Austria, Canada, Denmark, Finland, Greece, Slovakia, Spain
-
University Hospital, BrestCompletedStroke, Ischemic | Stroke HemorrhagicFrance
-
Sheffield Teaching Hospitals NHS Foundation TrustUnknownFatigue | Stroke, Ischemic | Stroke HemorrhagicUnited Kingdom
-
Umbria Bioengineering TechnologiesRecruitingStroke, Ischemic | Stroke HemorrhagicItaly
-
BayerRecruitingAcute Non-cardioembolic Ischemic Stroke | Prevention of Ischemic Stroke | High-risk Transient Ischemic AttackUnited States, Switzerland, Belgium, Australia, Sweden, Canada, Taiwan, Spain, Korea, Republic of, Latvia, Israel, Malaysia, China, Greece, Japan, Turkey, Netherlands, Romania, United Kingdom, Portugal, Hungary, Italy, Brazil, France, S... and more
-
University of AlbertaCompletedTransient Ischemic Attack | Minor Ischemic StrokeCanada
-
Stephanie HarrisonActive, not recruitingTransient Ischemic Attack | Stroke, IschemicUnited Kingdom
Clinical Trials on Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
-
University Hospital HeidelbergCompletedIschemic Stroke | Hemorrhagic StrokeGermany
-
University Hospital HeidelbergCompletedIschemic Stroke | Hemorrhagic StrokeGermany