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NCT Number: NCT01584180

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

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.

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Key information

Conditions

Ischemic Stroke Body Temperature Changes Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Hemorrhagic Stroke Hypothermia Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold crystalloid infusions, 0.9%NaCl or Ringer's

Drug

Infusion of max. 1L cold crystalloid solution (4°C) over 15 minutes

EMCOOLS Brain.Pad

Device

Passive external neck cooling with 1 EMCOOLS Brain.Pad

Other names: Emergency Medical Cooling Systems AG, Wien, Austria

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Official study 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

Acronym: iCOOL 3

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 24, 2012
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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