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

NCT01933230 | Terminated Phase 1 Results

• 1 other identifier: 13-121-CCSICH
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Excel Cryo Cooling System Collar

OTHER

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

Interventions

Excel Cryo Cooling System DEVICE

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

Excel Cryo Cooling System Collar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cerebellar hemorrhages.
• Moribund state where the physician team doesn't believe the patient will survive.
• Patients who are being cared for with the intent of making them comfortable. DNR-CC (by Ohio law).
• Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could affect inflammation.
• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Cryothermic Systems, Inc.: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jose Javier Provencio, Faculty, Neuroinflammation Research Center
• Organization: Cleveland Clinic

provenj@ccf.org

216-445-242

Study Officials

• J. Javier Provencio

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: September 2, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2015

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)