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

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).

Study Overview

• Status: Terminated
• Conditions: Intracerebral Hemorrhage
• Intervention / Treatment: Device: Excel Cryo Cooling System

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature Reduction by 1 Degree Per Hour in the ICU Setting.	Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.	During the 2 hours of neck cooling
To Determine if Neck Cooling Affects Intracranial Pressure		During 2 hours of neck cooling
To Determine if Neck Cooling Affects Brain Temperature.		During the 2 hours of neck cooling

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: Cryothermic Systems, Inc.
• Investigators: Principal Investigator: J. Javier Provencio, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Actual): February 23, 2017
• Last Update Submitted That Met QC Criteria: January 6, 2017
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: 13-121-CCSICH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO