Clinical trial NCT01933230: Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)
Official title: Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Intracerebral Hemorrhage
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Cryothermic Systems, Inc.
First posted: 2013-09-02
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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).

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.

Eligibility 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.

Primary outcomes:
measure: Temperature Reduction by 1 Degree Per Hour in the ICU Setting.
timeFrame: During the 2 hours of neck cooling
measure: To Determine if Neck Cooling Affects Intracranial Pressure
timeFrame: During 2 hours of neck cooling
measure: To Determine if Neck Cooling Affects Brain Temperature.
timeFrame: During the 2 hours of neck cooling
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: J. Javier Provencio
role: PRINCIPAL_INVESTIGATOR
References: