Effects of Surface Cooling On Stroke Outcome triaL (COOL) (COOL)

Effects of Surface Cooling On Stroke Outcome triaL: a Feasibility and Safety Study

The investigators goal is to improve the outcome of patients with acute stroke by inducing mild cerebral hypothermia through surface cooling at the cervical and shoulder regions using EMCOOLS Brain.Pads®.

For this project, the investigators can build further on their research group's experience with hypothermia in animal models and invasive cooling in stroke patients.

The COOL program will prospectively evaluate safety, feasibility, patient acceptance and efficacy of mild cerebral hypothermia using EMCOOLS Brain.Pads® in a large cohort of patients presenting with acute stroke at the Emergency Department of the Universitair Ziekenhuis Brussel. The application of EMCOOLS Brain.Pads® will be compared to routine clinical practice in a randomized controlled trial. If proven to be safe, feasible, well-tolerated and efficacious in the inhospital setting, future use in prehospital acute stroke care will be incorporated with telemedicine support, as part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB).

Study Overview

• Status: Unknown
• Conditions: Hypothermia; Acute Stroke

Detailed Description

Several studies have identified fever as an independent predictor of poor outcome in patients with acute stroke. Experimental data and clinical studies indicate that therapeutic hypothermia has neuroprotective effects associated with better clinical outcome, probably through reduction of infarct volume and cerebral edema in patients with ischemic and hemorrhagic stroke, respectively. It is to be expected that the beneficiary effects of hypothermia will be more pronounced if initiated early after stroke onset, which underlines the rational that this technique ideally should be initiated in the prehospital phase of acute stroke management.

Therapeutic hypothermia can be obtained by external or by endovascular cooling. Most methods aim to lower the body temperature to <33°C and therefore require patient sedation and intubation. In contrast to patients with cardiac arrest, sedation and intubation preferably are avoided and profound cooling of the entire body is not desired nor required in in stroke patients. EMCOOLS pads® have originally been developed by EMCOOLS Medical Cooling Systems AG (Austria) for profound external cooling of patients with cardiac arrest. The novel EMCOOLS Brain.Pad® was redesigned to mildly lower the brain temperature through noninvasive surface cooling of the cerebropetal arteries at the cervical level. Pilot studies in healthy volunteers demonstrated that a decrease of 0.5-1°C (tympanic measurement) can be safely obtained by application of EMCOOLS Brain.Pad® during 60 to 90 minutes. No relevant side effects were observed in these small studies, but possible effects on cerebrovascular blood flow were not evaluated.

Early application of mild therapeutic hypothermia in acute stroke patients builds further on their research group's experience with hypothermia in animal models and stroke patients. The investigators propose a prospective clinical trial comparing current clinical practice with the induction of mild hypothermia using EMCOOLS Brain.Pads® in patients presenting with acute stroke. If safety, feasibility, patient acceptance and efficacy are confirmed in the inhospital setting, the next step will involve evaluation of this approach in prehospital acute stroke care.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient older than 18 year presenting with an acute stroke and onset < 24 hours.

Description

Inclusion Criteria:

• Older than 18 years
• Acute stroke with onset < 24 hours

Exclusion Criteria:

• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Application of surface cooling; Surface cooling during 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of neurological deficit as measured by NIHSS	The National Institute of Health Stroke Scale (NIHSS) will be used as a measure to assess the gain in neurological deficit 90 days post-stroke.	90 days post-stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature change during surface cooling	Changes in temperature will be measured with mastoid, inguinal, tympanic and temporal thermometers.	During cooling and 30 minutes thereafter

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term functional outcome	The functional outcome will be measured by the modified Rankin Scale (mRS).	3 months post-stroke
Mortality rate		3 months post-stroke

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Robbert-Jan van Hooff, M.D., Ph.D., Universitair Ziekenhuis Brussel Belgium

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (Estimate): June 27, 2014

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Acute stroke; Therapeutic Hypothermia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Temperature Changes; Stroke; Hypothermia
• Other Study ID Numbers: B.U.N. 143201215226