Systemic Normothermia in Intracerebral Hemorrhage (ICH)

Completed · Early Phase 1

Conditions studied: Intracerebral Hemorrhage

In brief

Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either the experimental group which will keep them at a normal body temperature or the standard of care group. The investigators propose to test the hypothesis that prophylactic forced normothermia in patients with ICH leads to less systemic inflammation and decreased perihematomal edema.

Key facts

Study ID

NCT02078037

Run by

The Cleveland Clinic

People needed

9

Starts

2014-03-01

Expected to finish

2016-04-01

Last updated by the study team

2017-01-10

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with spontaneous supratentorial ICH >20 cc
• Age 18 to 85 years of age
• Consent from the patient or surrogate decision maker
• Within 24 hours of onset of ictus

You may not qualify if…

• Hemorrhage secondary to trauma, Arterio-venous malformation (AVM), aneurysm or Arterio-venous dural fistula
• Moribund state and deemed unlikely to survive until study completion (5 days)
• Patients with a don-not-resuscitate (DNR) order
• Known infection at the time of admission (elevated white blood cell count (WBC) with identified infection source).
• Evidence of a blood dyscrasia
• Pregnancy
• Renal failure (CCR < 50 ml/min)
• Contraindications for a brain MRI scan
• Infratentorial ICH
• Warfarin-induced intracerebral hemorrhages NOT corrected to International Normalized Ratio (INR) < 1.4 within 24 hours
• Episode of fever > 38.5 degrees Celsius prior to enrollment

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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