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

NCT ID: NCT01584180

Last Updated: 2012-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke Hemorrhagic Stroke

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cold infusions

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

Group Type ACTIVE_COMPARATOR

Cold crystalloid infusions, 0.9%NaCl or Ringer's

Intervention Type DRUG

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

EMCOOLS Brain.Pad

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

Group Type ACTIVE_COMPARATOR

EMCOOLS Brain.Pad

Intervention Type DEVICE

Passive external neck cooling with 1 EMCOOLS Brain.Pad

Interventions

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Cold crystalloid infusions, 0.9%NaCl or Ringer's

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

Intervention Type DRUG

EMCOOLS Brain.Pad

Passive external neck cooling with 1 EMCOOLS Brain.Pad

Intervention Type DEVICE

Other Intervention Names

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Emergency Medical Cooling Systems AG, Wien, Austria

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sven Poli

Dr. Sven Poli, Consultant Neurologist, Principial Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sven Poli, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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iCOOL 3

Identifier Type: -

Identifier Source: org_study_id