Clinical trial NCT00299416: Caffeinol Hypothermia Protocol
Official title: Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Nonhemorrhagic
hypothermia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2006-03-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 being cooled to 34.5 C.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Etiology other than ischemic stroke.
2. Item 1a on NIHSS \> 1
3. Signs/symptoms of subcortical, brainstem or cerebellar stroke.
4. Symptoms resolving or NIHSS \< 8 at time of each treatment.
5. NIHSS \> 20 if right hemisphere or \>25 if left hemisphere
6. Known alcoholic
7. Clinical or laboratory evidence of alcohol intoxication.
8. Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks.
9. Known hematologic dyscrasias that affect thrombosis.
10. Comorbid conditions likely to complicate therapy:

    1. End-stage cardiomyopathy
    2. Uncompensated or clinically significant arrhythmia
    3. Myopathy
    4. Liver disease
    5. History of pelvic or abdominal mass likely to compress inferior vena cava.
    6. End-stage AIDS
    7. History of clinically significant gastrointestinal (GI) bleeding
    8. Impaired renal function with creatinine clearance, 50 ml/min
11. Intracerebral / intraventricular hemorrhage
12. Systolic blood pressure (SBP) \> 210 or \< 100; diastolic blood pressure (DBP) \> 100 or \< 50 mmHg
13. Severe coagulopathy
14. Pregnancy
15. Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks
16. Known history of epilepsy.

Primary outcomes:
measure: Number of Participants With Symptomatic Intracerebral Hemorrhage
timeFrame: from pre-dosage to 90 day followup
measure: Number of Participants With Catheter Related Complications During Hypothermia & Rewarming
timeFrame: over 36 hour period
measure: Number of Participants With Cardiorespiratory Failure
timeFrame: every 30 minutes during hypothermia induction
Secondary outcomes:
measure: Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,
timeFrame: rewarming over 12 hours until 36.5C has been achieved
measure: Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.
timeFrame: rewarming over 12 hours until 36.5C has been achieved
measure: Efficacy: NIHSS < 2 at 24 Hours, Modified Rankin Scale (mRS) < 2 at 3 Months, NIHSS < 2 at 3 Months, and Length of Hospital and ICU Stay.
timeFrame: 90 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital - Medical Center
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: James C. Grotta, MD
role: PRINCIPAL_INVESTIGATOR
References: