NCT01584167

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Cold crystalloid infusions, 0.9%NaCl or Ringer's solution	Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
DEVICE	EMCOOLS Flex.Pads	Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-04-24
• Last updated: 2013-06-24

Locations

1 site across 1 country: Germany