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Effects of Surface Cooling On Stroke Outcome triaL (COOL)

NCT02176993 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2016-11-17

No results posted yet for this study

Summary

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).

Conditions

  • Acute Stroke
  • Hypothermia

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Robbert-Jan van Hooff, M.D., Ph.D. · Universitair Ziekenhuis Brussel Belgium

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02176993 on ClinicalTrials.gov