Caffeinol Hypothermia Protocol

Completed · Phase 1/Phase 2

Conditions studied: Acute Ischemic Stroke

In brief

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.

Key facts

Study ID

NCT00299416

Run by

The University of Texas Health Science Center, Houston

People needed

30

Starts

2003-02-01

Expected to finish

2009-08-01

Last updated by the study team

2011-05-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-80 years
• Clinical presentation of acute ischemic stroke
• Computed tomography (CT) scan compatible with acute ischemic stroke.
• Time to caffeinol treatment < 240 minutes from stroke onset.
• Time to hypothermia initiation < 300 minutes from stroke onset.
• Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut)
• National Institutes of Health Stroke Scale (NIHSS) > 8 at time of each treatment.
• Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA.

You may not qualify if…

• Etiology other than ischemic stroke.
• Item 1a on NIHSS > 1
• Signs/symptoms of subcortical, brainstem or cerebellar stroke.
• Symptoms resolving or NIHSS < 8 at time of each treatment.
• NIHSS > 20 if right hemisphere or >25 if left hemisphere
• Known alcoholic
• Clinical or laboratory evidence of alcohol intoxication.
• Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks.
• Known hematologic dyscrasias that affect thrombosis.
• Comorbid conditions likely to complicate therapy:
• End-stage cardiomyopathy
• Uncompensated or clinically significant arrhythmia
• Myopathy
• Liver disease
• History of pelvic or abdominal mass likely to compress inferior vena cava.
• End-stage AIDS
• History of clinically significant gastrointestinal (GI) bleeding
• Impaired renal function with creatinine clearance, 50 ml/min
• Intracerebral / intraventricular hemorrhage
• Systolic blood pressure (SBP) > 210 or < 100; diastolic blood pressure (DBP) > 100 or < 50 mmHg
• Severe coagulopathy
• Pregnancy
• Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks
• Known history of epilepsy.

Where it is running

• Memorial Hermann Hospital - Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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