Phase 2 Completed N=30 Treatment

Caffeinol Hypothermia Protocol

Stroke

Source: ClinicalTrials.gov NCT00299416 ↗

Enrolled (actual)

Serious AEs

30.0%

Results posted

May 2011

Primary outcomePrimary: Number of Participants With Symptomatic Intracerebral Hemorrhage — 0 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Symptomatic Intracerebral Hemorrhage	—	—
PRIMARY Number of Participants With Catheter Related Complications During Hypothermia & Rewarming	—	—
PRIMARY Number of Participants With Cardiorespiratory Failure	—	—
SECONDARY Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,	—	—
SECONDARY Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.	—	—
SECONDARY 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.	—	—

Eligibility Criteria

Inclusion Criteria

Age 18-80 years
Clinical presentation of acute ischemic stroke
Computed tomography (CT) scan compatible with acute ischemic stroke.
Time to caffeinol treatment 8 at time of each treatment.
Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA.

Exclusion Criteria

Etiology other than ischemic stroke.
Item 1a on NIHSS > 1
Signs/symptoms of subcortical, brainstem or cerebellar stroke.
Symptoms resolving or 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 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.

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Data sourced from ClinicalTrials.gov (NCT00299416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.