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A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Brain.Pad (iCOOL 3) (iCOOL 3)

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ClinicalTrials.gov Identifier: NCT01584180
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg

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 Brain.Pad (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 the EMCOOLS Brain.Pad on brain-temperature measured. For the first time iCOOL 3 compares feasibility, safety and efficacy of the two methods.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Hemorrhagic Stroke Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's Device: EMCOOLS Brain.Pad Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: iCOOL 3 (Induction of COOLing 3): A Randomized Trial Comparing 2 Methods for Rapid Induction of Cooling in Stroke Patients, Cold Infusions vs. EMCOOLS Brain.Pad
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
Active Comparator: Cold infusions
Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's
Infusion of max. 1L cold crystalloid solution (4°C) over 15 minutes

Active Comparator: EMCOOLS Brain.Pad
Passive external neck cooling with 1 EMCOOLS Brain.Pad (Emergency Medical Cooling Systems AG, Wien, Austria)
Device: EMCOOLS Brain.Pad
Passive external neck cooling with 1 EMCOOLS Brain.Pad
Other Name: Emergency Medical Cooling Systems AG, Wien, Austria




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. (Neuro-)vital parameters [ Time Frame: -15 to +180 min ]
    Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered

  2. 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.

  3. Safety [ Time Frame: 0 - 7 days ]
    Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 Brain.Pad

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584180


Locations
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Germany
Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Principal Investigator: Sven Poli, Dr. med. University Hospital Heidelberg

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Responsible Party: Dr. Sven Poli, Dr. Sven Poli, Consultant Neurologist, Principial Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01584180     History of Changes
Other Study ID Numbers: iCOOL 3
First Posted: April 24, 2012    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Dr. Sven Poli, University Hospital Heidelberg:
local neck cooling
hypothermia
induction of hypothermia
cold infusion
external cooling
surface cooling
non invasive cooling
stroke
intracranial hemorrhage
cerebrovascular disease
neuro intensive care

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases