Caffeinol is a combination of caffeine and alcohol. The amount given is about the same as 1-2 glasses of wine and 3-4 cups of coffee. The patient receives a one time dose given over two hour while being cooled to 34.5 C.
- Hypothermia Device
Intervention Desc: External or internal cooling for 24 hours and rewarming over 12 hours.
- Caffeinol Drug
Intervention Desc: Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.
- Allocation: Non-Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Single Group Assignment
Patient will receive drug, Caffeinol as an infusion(9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours. Patient will also undergo hypothermia(external or internal cooling) for 24 hours and rewarming over 12 hours.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Safety: symptomatic hemorrhage, catheter-related complications, infections, cardiorespiratory failure, arrhythmias.|
|Secondary||Feasibility: time required to reach the target core temperature or lowest tolerated temperature, stability of patient temperature, control of rewarming; achievement of therapeutic serum ethanol and caffeine levels, and amount of sedation needed to suppress shivering; efficacy: NIHSS < 2 at 24 hours, mRS < 2 at 3 months, NIHSS < 2 at 3 months, and length of hospital and ICU stay.|
|Primary||Number of Participants With Symptomatic Intracerebral Hemorrhage||from pre-dosage to 90 day followup||Yes|
|Primary||Number of Participants With Catheter Related Complications During Hypothermia & Rewarming||over 36 hour period||Yes|
|Primary||Number of Participants With Cardiorespiratory Failure||every 30 minutes during hypothermia induction||Yes|
|Secondary||Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,||rewarming over 12 hours until 36.5C has been achieved||No|
|Secondary||Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.||rewarming over 12 hours until 36.5C has been achieved||Yes|
|Secondary||Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay.||90 days||No|