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Closed due to issues encountered with meeting enrollment goals at our site.
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| Name | Class |
|---|---|
| Cryothermic Systems, Inc. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Javier Provencio | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Excel Cryo Cooling System Collar | We will place an Excel Cryo Cooling System collar around your 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 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). Excel Cryo Cooling System: We will place an Excel Cryo Cooling System collar around your neck for two hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | degrees celsius | During the 2 hours of neck cooling |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Excel Cryo Cooling System Collar | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jose Javier Provencio, Faculty, Neuroinflammation Research Center | Cleveland Clinic | 216-445-242 | provenj@ccf.org |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| temperature | Mean | Standard Deviation | degrees celsius |
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| Primary | To Determine if Neck Cooling Affects Intracranial Pressure | Not Posted | During 2 hours of neck cooling | Participants |
| Primary | To Determine if Neck Cooling Affects Brain Temperature. | Not Posted | During the 2 hours of neck cooling | Participants |
| 0 |
| 2 |
| 0 |
| 2 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |