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

Stopped early · Phase 1

Conditions studied: Intracerebral Hemorrhage

In brief

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).

Key facts

Study ID

NCT01933230

Run by

The Cleveland Clinic

People needed

2

Starts

2013-06-01

Expected to finish

2014-09-01

Last updated by the study team

2017-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with brain injury in the Neurological ICU.
• Consent from the patient or surrogate decision maker.
• Warfarin induced intracerebral hemorrhages only after correction of INR to <1.4.

You may not qualify if…

• Cerebellar hemorrhages.
• Moribund state where the physician team doesn't believe the patient will survive.
• Patients who are being cared for with the intent of making them comfortable. DNR-CC (by Ohio law).
• Known history of a blood dyscrasia such as CLL or essential thrombocytosis that could affect inflammation.
• 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.

Where it is running

• The Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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