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

NCT ID: NCT01584167

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-12-31

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 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.

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cold infusions

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

EMCOOLS Flex.Pads

Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria)

Group Type: ACTIVE_COMPARATOR

EMCOOLS Flex.Pads

Intervention Type: DEVICE

Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads

Interventions

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

Infusion of 2L cold crystalloid solution (4°C) over 30 minutes

Intervention Type: DRUG

EMCOOLS Flex.Pads

Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads

Intervention Type: DEVICE

Other Intervention Names

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 Flex.Pads

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Dr. Sven Poli

Dr. Sven Poli, Consultant Neurologist, Principical Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sven Poli, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sven Poli, Dr. med.

Role: CONTACT

sven.poli@med.uni-heidelberg.de

0049 6221 56 ext. 0

Other Identifiers

iCOOL 2

Identifier Type: -

Identifier Source: org_study_id