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

This study is currently recruiting participants.
Verified June 2013 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Dr. Sven Poli, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT01584167
First received: April 21, 2012
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Ischemic Stroke
Hemorrhagic Stroke
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
Device: EMCOOLS Flex.Pads
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • Brain temperature [ Time Frame: -15 to +60min ] [ Designated as safety issue: No ]
    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:
  • (Neuro-)vital parameters [ Time Frame: -15 to +180 min ] [ Designated as safety issue: Yes ]
    Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered

  • Cerebral autoregulation [ Time Frame: 15 to +180 min ] [ Designated as safety issue: No ]
    Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.

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


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cold infusions
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution
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)
Device: EMCOOLS Flex.Pads
Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
Other Name: Emergency Medical Cooling Systems AG, Wien, Austria

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 Flex.Pads
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584167

Contacts
Contact: Sven Poli, Dr. med. 0049 6221 56 ext 0 sven.poli@med.uni-heidelberg.de

Locations
Germany
Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Sven Poli, Dr. med.         
Sub-Investigator: Jan C Purrucker, Dr. med.         
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Sven Poli, Dr. med. University Hospital Heidelberg
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Sven Poli, Dr. Sven Poli, Consultant Neurologist, Principical Investigator, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT01584167     History of Changes
Other Study ID Numbers: iCOOL 2
Study First Received: April 21, 2012
Last Updated: June 21, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Heidelberg:
stroke
hypothermia
induction of hypothermia
cold infusion
whole-body cooling
external cooling
surface cooling
non invasive cooling
intracranial hemorrhage
cerebrovascular disease
neuro intensive care

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014