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

June 21, 2013 updated by: Dr. Sven Poli, University Hospital Heidelberg

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Heidelberg, Germany, 69120
        • Recruiting
        • Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg
        • Principal Investigator:
          • Sven Poli, Dr. med.
        • Sub-Investigator:
          • Jan C Purrucker, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cold infusions
Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
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)
Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
Other Names:
  • Emergency Medical Cooling Systems AG, Wien, Austria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
-15 to +60min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Neuro-)vital parameters
Time Frame: -15 to +180 min
Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered
-15 to +180 min
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.
15 to +180 min
Safety
Time Frame: 0 - 7 days
Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.
0 - 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sven Poli, Dr. med., University Hospital Heidelberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

April 21, 2012

First Submitted That Met QC Criteria

April 21, 2012

First Posted (Estimate)

April 24, 2012

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 21, 2013

Last Verified

June 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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