Ischemic StrokePhase 2iCOOL 2NCT01584167
A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Flex.Pads (iCOOL 2)
A Phase 2 study testing Cold crystalloid infusions, 0.9%NaCl or Ringer's solution and EMCOOLS Flex.Pads in people with Ischemic Stroke and Hemorrhagic Stroke, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke
- What is being tested?
- Cold crystalloid infusions, 0.9%NaCl or Ringer's solution and EMCOOLS Flex.Pads
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sedation
- Combined ICP-temperature-probe
- Indication to lower body temperature > 1.5°C
- Age ≥ 18 years
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Heidelberg, 69120
Sven Poli, Dr. med.
Jan C Purrucker, Dr. med.
About this study
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
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.
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- Cold crystalloid infusions, 0.9%NaCl or Ringer's solution, EMCOOLS Flex.Pads
- 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
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Hypothermia, Stroke, Intracranial Hemorrhages, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionDrug
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
EMCOOLS Flex.PadsDevice
Also called Emergency Medical Cooling Systems AG, Wien, Austria
Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
| Study group | Role | What they receive |
|---|---|---|
| Cold infusions | Active comparator | Infusion of 2L cold crystalloid solution (4°C) over 30 minutes Receives: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution |
| EMCOOLS Flex.Pads | Active comparator | Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) Receives: Device: EMCOOLS Flex.Pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: -15 to +60min
Secondary outcomes (3)
(Neuro-)vital parameters
Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered
Measured: -15 to +180 min
Cerebral autoregulation
Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
Measured: 15 to +180 min
Safety
Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.
Measured: 0 - 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sven Poli, University Hospital Heidelberg
- Investigators
- Sven Poli, Dr. med., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584167
- Sponsor's protocol ID
- iCOOL 2
- Acronym
- iCOOL 2
- Status last verified
- Jun 2013
- First submitted
- 21 Apr 2012
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01584167
- Acronym / sponsor ID
- iCOOL 2 / iCOOL 2
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke
- Keywords
- hypothermia, induction of hypothermia, cold infusion, whole-body cooling, external cooling, surface cooling, non invasive cooling, stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold infusions | Active comparator | Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionInfusion of 2L cold crystalloid solution (4°C) over 30 minutes |
| EMCOOLS Flex.Pads | Active comparator | Device: EMCOOLS Flex.PadsPassive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sedation
- Combined ICP-temperature-probe
- Indication to lower body temperature > 1.5°C
- Age ≥ 18 years
Key exclusion criteria (11 listed)
- Body weight > 120 kg
- Severe renal insufficiency
- Acute pulmonary embolism
- Acute myocardial infarction
- High-grade heart valve stenosis or insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionInfusion of 2L cold crystalloid solution (4°C) over 30 minutes | Drug | Cold infusions |
| EMCOOLS Flex.PadsAlso: Emergency Medical Cooling Systems AG, Wien, AustriaPassive whole-body surface cooling with 10 EMCOOLS Flex.Pads | Device | EMCOOLS Flex.Pads |
Primary outcome
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)
3 secondary outcomes
(Neuro-)vital parameters
Time frame: -15 to +180 min
Cerebral autoregulation
Time frame: 15 to +180 min
Safety
Time frame: 0 - 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Heidelberg HYPOthermia 24/7 - Research group, information and contactsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Poli, Dr. med. principal investigator
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cold crystalloid infusions, 0.9%NaCl or Ringer's solution and EMCOOLS Flex.Pads in people with Ischemic Stroke and Hemorrhagic Stroke, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sven Poli, Dr. med. (0049 6221 56 ext. 0, sven.poli@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain temperature (time frame: -15 to +60min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.