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

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ClinicalTrials.gov Identifier: NCT01933230
Recruitment Status : Terminated (Closed due to issues encountered with meeting enrollment goals at our site.)
First Posted : September 2, 2013
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
Cryothermic Systems, Inc.
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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).

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Device: Excel Cryo Cooling System Phase 1

Detailed Description:
This is a non-randomized device efficacy trial. Patients with >20cc Supratentorial ICH and an invasive brain temperature monitor (either Licox or Temperature sensing intracranial pressure device) will be enrolled after consent. The Excel Cryo Cooling System collar will be placed around neck in up to 20 patients for two hours. The goal is to determine the effectiveness of this device in cooling the brain. 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 that delivers the cold. During the study and for two hours after, the investigators will collect data concerning the brain temperature, body temperature, brain oxygen level and pressure both in the head and in the blood (blood pressure). The investigators will also collect demographic information about you (i.e. age, gender, medical risk factors) and information regarding your current disease process.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)
Study Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014


Arm Intervention/treatment
Excel Cryo Cooling System Collar
An Excel Cryo Cooling System collar will be placed around the neck for a 2 hour neck cooling period. 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.
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





Primary Outcome Measures :
  1. Temperature Reduction by 1 Degree Per Hour in the ICU Setting. [ Time Frame: During the 2 hours of neck cooling ]
    Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.

  2. To Determine if Neck Cooling Affects Intracranial Pressure [ Time Frame: During 2 hours of neck cooling ]
  3. To Determine if Neck Cooling Affects Brain Temperature. [ Time Frame: During the 2 hours of neck cooling ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with brain injury in the Neurological ICU.
  2. Consent from the patient or surrogate decision maker.
  3. Warfarin induced intracerebral hemorrhages only after correction of INR to <1.4.

Exclusion Criteria:

  1. Cerebellar hemorrhages.
  2. Moribund state where the physician team doesn't believe the patient will survive.
  3. Patients who are being cared for with the intent of making them comfortable. DNR-CC (by Ohio law).
  4. Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could affect inflammation.
  5. Known significant carotid artery stenosis (known >50% stenosis by history or incidental hospital imaging). This will not be specifically tested. Patients found to have significant stenosis later in the hospital stay will have their data interpreted separately as well as in the total group.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01933230


Locations
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United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Cryothermic Systems, Inc.
Investigators
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Principal Investigator: J. Javier Provencio The Cleveland Clinic

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01933230     History of Changes
Other Study ID Numbers: 13-121-CCSICH
First Posted: September 2, 2013    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2017
Last Verified: February 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cerebral Hemorrhage
Brain Diseases
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents