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Caffeinol Hypothermia Protocol

The University of Texas System (UT) logo

The University of Texas System (UT)

Status and phase

Completed
Phase 2
Phase 1

Conditions

Acute Ischemic Stroke

Treatments

Procedure: hypothermia
Drug: Caffeinol

Study type

Interventional

Funder types

Other

Identifiers

NCT00299416
HSC- MS-02-188
P50NS44277 project #1

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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