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

Intracerebral Hemorrhage Clinical Trial

— CCSICH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01933230
• Other study ID #: 13-121-CCSICH
• Status: Terminated
• Phase: Phase 1
• First received: August 23, 2013
• Last updated: February 2, 2015
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Device:
• Excel Cryo Cooling System
We will place an Excel Cryo Cooling System collar around your neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. 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. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure). 2 hour neck cooling period

Locations

Country	Name	City	State
United States	The Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	Cryothermic Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine if Temperature Can be Reduced by 1 Degree Per Hour in the ICU Setting.	We will monitor body temperature	During the 2 hours of neck cooling	No
Primary	To Determine if Neck Cooling Affects Intracranial Pressure		During 2 hours of neck cooling	No
Primary	To Determine if Neck Cooling Affects Brain Temperature.		During the 2 hours of neck cooling	No