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Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)

NCT01933230 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-02-23

Study results available
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Summary

The purpose of this study is to determine if cooling the neck of patients with ICH decreases brain temperature. In addition, the investigators will determine if the device improves the delivery of oxygen to the brain. A third goal is to determine if cooling the neck lowers intracranial pressure (which is often times high in patients after ICH).

Conditions

  • Intracerebral Hemorrhage

Interventions

DEVICE

Excel Cryo Cooling System

An Excel Cryo Cooling System collar will be place around the neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar. The cooling pack is similar to the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration. During the study and for two hours after, we will collect data concerning the brain temperature, body temperature, brain oxygen level, and pressure both in the head and in the blood. 2 hour neck cooling period

Sponsors & Collaborators

  • Cryothermic Systems, Inc.

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • J. Javier Provencio · The Cleveland Clinic

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States

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 NCT01933230 on ClinicalTrials.gov