Caffeinol Hypothermia Protocol

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)