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

Phase 2

• Conditions: Ischemic Stroke; Hemorrhagic Stroke
• Interventions: Drug: Cold crystalloid infusions, 0.9%NaCl or Ringer's solution; Device: EMCOOLS Flex.Pads

• Registration Number: NCT01584167
• Lead Sponsor: University Hospital Heidelberg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-21
• Study First Submitted QC: 2012-04-21
• Study First Posted: 2012-04-24
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-06-24
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cold infusions	Cold crystalloid infusions, 0.9%NaCl or Ringer's solution	Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
EMCOOLS Flex.Pads	EMCOOLS Flex.Pads	Passive surface cooling with 10 EMCOOLS Flex.Pads (Emergency Medical Cooling Systems AG, Wien, Austria)

Primary Outcome Measures

Name	Time	Method
Brain temperature	-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)

Secondary Outcome Measures

Name	Time	Method
(Neuro-)vital parameters	-15 to +180 min	Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered
Cerebral autoregulation	15 to +180 min	Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.
Safety	0 - 7 days	Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.

Trial Locations

Locations (1)

Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany