NCT01933230

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracerebral Hemorrhage

Interventions

Type	Name	Description
DEVICE	Excel 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

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-09-02
• Last updated: 2017-02-23
• Results posted: 2015-02-23

Locations

1 site across 1 country: United States