Status:
COMPLETED
Caffeinol Hypothermia Protocol
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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 bei...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00299416
Start Date
February 1 2003
End Date
August 1 2009
Last Update
May 3 2011
Active Locations (1)
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1
Memorial Hermann Hospital - Medical Center
Houston, Texas, United States, 77030