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

Ischemic Stroke Clinical Trial

— iCOOL 2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01584167
• Other study ID #: iCOOL 2
• Status: Recruiting
• Phase: Phase 2
• First received: April 21, 2012
• Last updated: June 21, 2013
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: University Hospital Heidelberg
• Contact: Sven Poli, Dr. med.
• Phone: 0049 6221 56
• Email: sven.poli[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Germany	Neuro Intensive Care Unit 2, Dept. of Neurology, University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain temperature	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)	-15 to +60min	No
Secondary	(Neuro-)vital parameters	Effects on (neuro-)vital parameters (e.g. HR, AP, ICP, CPP) are registered	-15 to +180 min	Yes
Secondary	Cerebral autoregulation	Cerebral auto-regulation parameters (e.g. PRx) are calculated on the basis of the (neuro-)vital parameters monitored.	15 to +180 min	No
Secondary	Safety	Various safety parameters, such as bleeding complications, cardiac decompensation, or local skin irritations are assessed.	0 - 7 days	Yes

External Links

•   Heidelberg HYPOthermia 24/7 - Research group, information and contacts