Trial Outcomes & Findings for Trial of Cooling for Patients With Excel Cryo Cooling System in Intracerebral Hemorrhage (ICH) (NCT NCT01933230)

Results Overview

Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

2 participants

Primary outcome timeframe

During the 2 hours of neck cooling

Results posted on

2017-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Excel Cryo Cooling System Collar n=2 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 2.83 • n=5 Participants
Gender Female	2 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
temperature	37.05 degrees celsius STANDARD_DEVIATION 0.354 • n=5 Participants

PRIMARY outcome

Timeframe: During the 2 hours of neck cooling

Temperature reduction by 1 degree per hour in the Intensive Care Unit setting.

Outcome measures

Outcome measures
Measure	Excel Cryo Cooling System Collar n=2 Participants 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).
Temperature Reduction by 1 Degree Per Hour in the ICU Setting.	37.05 degrees celsius Standard Deviation 0.354

PRIMARY outcome

Timeframe: During 2 hours of neck cooling

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: During the 2 hours of neck cooling

Outcome measures

Outcome data not reported

Adverse Events

Excel Cryo Cooling System Collar

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jose Javier Provencio, Faculty, Neuroinflammation Research Center

Cleveland Clinic

Phone: 216-445-242

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place