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

NCT01584180 | Completed Phase 2

• 1 other identifier: iCOOL 3
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Keywords

hypothermia; induction of hypothermia; cold infusion; local neck cooling; external cooling; surface cooling; non invasive cooling; stroke; intracranial hemorrhage; cerebrovascular disease; neuro intensive care

Outcome Measures

Primary Outcomes (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)

  -15 to +60min

Secondary Outcomes (3)

• (Neuro-)vital parameters

  -15 to +180 min

• Cerebral autoregulation

  15 to +180 min

• Safety

  0 - 7 days

Study Arms (2)

Cold infusions

ACTIVE COMPARATOR

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

Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's

EMCOOLS Brain.Pad

ACTIVE COMPARATOR

Passive external neck cooling with 1 EMCOOLS Brain.Pad (Emergency Medical Cooling Systems AG, Wien, Austria)

Device: EMCOOLS Brain.Pad

Interventions

Cold crystalloid infusions, 0.9%NaCl or Ringer's DRUG

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

Cold infusions

EMCOOLS Brain.Pad DEVICE

Passive external neck cooling with 1 EMCOOLS Brain.Pad

Also known as: Emergency Medical Cooling Systems AG, Wien, Austria

EMCOOLS Brain.Pad

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sedation
• Combined ICP-temperature-probe
• Indication to lower body temperature ≤ 1.5°C
• Age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

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

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Hypothermia; Stroke; Intracranial Hemorrhages; Cerebrovascular Disorders

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sven Poli, Dr. med.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sven Poli, Consultant Neurologist, Principial Investigator

Study Record Dates

• First Submitted: April 21, 2012
• First Posted: April 24, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

DE (1)