Intracerebral Hemorrhage
Conditions
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.
Interventions
DEVICEExcel 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
Sponsors
Cryothermic Systems, Inc.
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature Reduction by 1 Degree Per Hour in the ICU Setting. | During the 2 hours of neck cooling | Temperature reduction by 1 degree per hour in the Intensive Care Unit setting. |
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Excel Cryo Cooling System Collar We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. 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).
We will place an Excel Cryo Cooling System collar around your neck for two hours. 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 | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Excel Cryo Cooling System Collar |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 2.83 |
| Gender Female | 2 Participants |
| Gender Male | 0 Participants |
| Region of Enrollment United States | 2 participants |
| temperature | 37.05 degrees celsius STANDARD_DEVIATION 0.354 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Temperature Reduction by 1 Degree Per Hour in the ICU Setting.
Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.
Time frame: During the 2 hours of neck cooling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Excel Cryo Cooling System Collar | Temperature Reduction by 1 Degree Per Hour in the ICU Setting. | 37.05 degrees celsius | Standard Deviation 0.354 |
Primary
To Determine if Neck Cooling Affects Brain Temperature.
Time frame: During the 2 hours of neck cooling
Primary
To Determine if Neck Cooling Affects Intracranial Pressure
Time frame: During 2 hours of neck cooling