Phase 2
N=30
Caffeinol Hypothermia Protocol
Acute Ischemic Stroke
Bottom Line
View on ClinicalTrials.gov: NCT00299416 ↗Enrolled (actual)
30
Serious AEs
30.0%
Results posted
May 2011
Primary outcome: Primary: Number of Participants With Symptomatic Intracerebral Hemorrhage — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Caffeinol (Drug); hypothermia (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Jan 2009
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. |
— | — |
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
- 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.
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.