NCT01584167

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

1.9 years

First QC Date

April 21, 2012

Last Update Submit

June 21, 2013

Conditions

Ischemic StrokeHemorrhagic Stroke

Keywords

hypothermiainduction of hypothermiacold infusionwhole-body coolingexternal coolingsurface coolingnon invasive coolingstrokeintracranial hemorrhagecerebrovascular diseaseneuro intensive care

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • (Neuro-)vital parameters

    -15 to +180 min

  • Cerebral autoregulation

    15 to +180 min

  • Safety

    0 - 7 days

Study Arms (2)

Cold infusions

ACTIVE COMPARATOR

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

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

EMCOOLS Flex.Pads

ACTIVE COMPARATOR

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

Device: EMCOOLS Flex.Pads

Interventions

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

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

Cold infusions
EMCOOLS Flex.PadsDEVICE

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

Also known as: Emergency Medical Cooling Systems AG, Wien, Austria
EMCOOLS Flex.Pads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedation
  • Combined ICP-temperature-probe
  • Indication to lower body temperature \> 1.5°C
  • Age ≥ 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic StrokeHypothermiaStrokeIntracranial HemorrhagesCerebrovascular Disorders

Interventions

Sodium ChlorideRinger's Solution

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHemorrhagePathologic Processes

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sven Poli, Dr. med.

    University Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sven Poli, Dr. med.

CONTACT

0049 6221 56sven.poli@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Sven Poli, Consultant Neurologist, Principical Investigator

Study Record Dates

First Submitted

April 21, 2012

First Posted

April 24, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

DE(1)