Caffeinol Hypothermia Protocol

NCT ID: NCT00299416

Last Updated: 2011-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Caffeinol

Infusion of caffeinol (9mg/kg caffeine + 0.4g/kg ethanol) over 2 hours.

Intervention Type: DRUG

hypothermia

External or internal cooling for 24 hours and rewarming over 12 hours.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

UT- Houston Health Science Center, Department of Neurology

Principal Investigators

James C. Grotta, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Memorial Hermann Hospital - Medical Center

Houston, Texas, United States

Countries

United States

Other Identifiers

P50NS44277 project #1

Identifier Type: -

Identifier Source: secondary_id

HSC- MS-02-188

Identifier Type: -

Identifier Source: org_study_id