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

University Hospital Heidelberg

Status and phase: Unknown; Phase 2

Conditions: Ischemic Stroke; Hemorrhagic Stroke

Treatments: Device: EMCOOLS Flex.Pads; Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01584167

iCOOL 2

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Cold infusions

Active Comparator group

Description:

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

Treatment:

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

EMCOOLS Flex.Pads

Active Comparator group

Description:

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

Treatment:

Device: EMCOOLS Flex.Pads