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

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

Sponsors

Lead Sponsor: University Hospital Heidelberg

Source 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.

Overall Status Completed
Start Date January 2012
Completion Date May 2012
Primary Completion Date May 2012
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Brain temperature -15 to +60min
Secondary Outcome
Measure Time Frame
(Neuro-)vital parameters -15 to +180 min
Cerebral autoregulation 15 to +180 min
Safety 0 - 7 days
Enrollment 20
Condition
Intervention

Intervention Type: Drug

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

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

Arm Group Label: Cold infusions

Intervention Type: Device

Intervention Name: EMCOOLS Brain.Pad

Description: Passive external neck cooling with 1 EMCOOLS Brain.Pad

Arm Group Label: EMCOOLS Brain.Pad

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

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Sven Poli, Dr. med. Principal Investigator University Hospital Heidelberg
Location
Facility: Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
Location Countries

Germany

Verification Date

August 2012

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University Hospital Heidelberg

Investigator Full Name: Dr. Sven Poli

Investigator Title: Dr. Sven Poli, Consultant Neurologist, Principial Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cold infusions

Type: Active Comparator

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

Label: EMCOOLS Brain.Pad

Type: Active Comparator

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

Acronym iCOOL 3
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov