Ischemic StrokePhase 2iCOOL 1NCT01573117

A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill (iCOOL 1)

A Phase 2 study testing RhinoChill and Cold crystalloid infusions, 0.9%NaCl or Ringer's solution in people with Ischemic Stroke and Hemorrhagic Stroke, run by University Hospital Heidelberg at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Ischemic Stroke, Hemorrhagic Stroke
What is being tested?: RhinoChill and Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
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: Sep 2010to Nov 2011
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, intubation and mechanical ventilation
Combined ICP-temperature-probe
Indication to lower body temperature
Age ≥ 18 years

Who cannot join

Body weight > 120 kg
Fever > 38.5°C
Chronic sinusitis
Current or past fracture or surgery of the paranasal sinuses
Severe infection with bacteremia or sepsis ≤ 72 h
Severe renal insufficiency

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Severe liver insufficiency
Acute pulmonary embolism
Acute myocardial infarction
Severe cardiac insufficiency (NYHA ≥ III)
Threatening ventricular dysrhythmia
Cardiac dysrhythmia with bradycardia (heart rate < 50 /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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Heidelberg, 69120

Other trials in Germany

About this study

Official title: iCOOL 1 (Induction of COOLing 1): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill

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. The RhinoChill (BeneChill, USA) is a new device. A comparison of these two induction methods has never been done before. Neither was the effect of cold infusions on brain-temperature measured. For the first time iCOOL 1 compares feasibility, safety and efficacy of the two methods.

Conditions: Ischemic Stroke, Hemorrhagic Stroke
Being tested: RhinoChill, Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Keywords: hypothermia, induction of hypothermia, cold infusion, nasopharyngeal 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.

RhinoChillDevice
Also called BeneChill, USA
Nasopharyngeal cooling with the RhinoChill device
Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionDrug
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Study groups in NCT01573117
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
RhinoChill	Active comparator	Nasopharyngeal cooling with the RhinoChill device (BeneChill, USA) Receives: Device: RhinoChill

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 +60 min
Cerebral autoregulation
Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
Measured: -15 to +60 min
Safety
Various safety parameters, such as bleeding complications, cardiac decompensation, or local irritations in the nasopharynx are assessed.
Measured: 0-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Nov 2011

First posted6 Apr 2012 (estimated)
Study startSep 2010
Primary completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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 (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01573117
Sponsor's protocol ID: iCOOL 1
Acronym: iCOOL 1
Status last verified: Apr 2012
First submitted: 31 Mar 2012
Last updated: 26 Apr 2012
Results posted: No
Data monitoring committee: No

Publications

Poli S, Purrucker J, Priglinger M, Ebner M, Sykora M, Diedler J, Bulut C, Popp E, Rupp A, Hametner C. Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling. Crit Care. 2014 Oct 27;18(5):582. doi: 10.1186/s13054-014-0582-1.
PubMed 25346332

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: iCOOL 1 (Induction of COOLing 1): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. RhinoChill
ClinicalTrials.gov ID: NCT01573117
Acronym / sponsor ID: iCOOL 1 / iCOOL 1
Conditions: Ischemic Stroke, Hemorrhagic Stroke
Keywords: hypothermia, induction of hypothermia, cold infusion, nasopharyngeal cooling, stroke, intracranial hemorrhage, cerebrovascular disease, neuro intensive care
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University Hospital HeidelbergUniversity, hospital or other
Study start: Sep 2010
Primary completion: Nov 2011 (actual)
First posted: 6 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.

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
RhinoChill	Active comparator	Device: RhinoChillNasopharyngeal cooling with the RhinoChill device (BeneChill, USA)

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, intubation and mechanical ventilation
Combined ICP-temperature-probe
Indication to lower body temperature
Age ≥ 18 years

Key exclusion criteria (14 listed)

Body weight > 120 kg
Fever > 38.5°C
Chronic sinusitis
Current or past fracture or surgery of the paranasal sinuses
Severe infection with bacteremia or sepsis ≤ 72 h

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
RhinoChillAlso: BeneChill, USANasopharyngeal cooling with the RhinoChill device	Device	RhinoChill
Cold crystalloid infusions, 0.9%NaCl or Ringer's solutionInfusion of 2L cold crystalloid solution (4°C) over 30 minutes	Drug	Cold infusions

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 +60 min
Cerebral autoregulation
Time frame: -15 to +60 min
Safety
Time frame: 0-6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2012.
Derived from this study: PubMed 25346332Poli S, Purrucker J, Priglinger M, Ebner M, Sykora M, Diedler J, Bulut C, Popp E, Rupp A, Hametner C. Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling. Crit Care. 2014 Oct 27;18(5):582. doi: 10.1186/s13054-014-0582-1.
Heidelberg HYPOthermia 24/7 - Research group, information and contactsLink provided by the sponsor.

Related trials for Ischemic Stroke

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
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RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
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Recruiting
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Recruiting
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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?

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 14 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: finished, as of the sponsor's last update on 26 Apr 2012. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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?

On the ClinicalTrials.gov record for NCT01573117, which also lists 1 linked publication.

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 26 Apr 2012.