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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

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?
RhinoChill and Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
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.

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 groupRoleWhat they receive
Cold infusionsActive comparatorInfusion of 2L cold crystalloid solution (4°C) over 30 minutes
Receives: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
RhinoChillActive comparatorNasopharyngeal 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.

  1. 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)

  1. (Neuro-)vital parameters

    Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered.

    Measured: -15 to +60 min

  2. 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

  3. 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.

  1. First posted6 Apr 2012 (estimated)
  2. Study startSep 2010
  3. Primary completionNov 2011

Resources

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

Questions about this trial

What is this clinical trial studying?

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.

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.

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