Caffeinol Hypothermia Protocol - Full Text View

Sponsored by:	The University of Texas Health Science Center, Houston
Information provided by:	The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:	NCT00299416

Purpose

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.

Condition	Intervention	Phase
Acute Ischemic Stroke	Drug: Caffeinol Procedure: hypothermia	Phase I Phase II

MedlinePlus related topics: Caffeine Hypothermia

Drug Information available for: Ethanol 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:

Safety: symptomatic hemorrhage, catheter-related complications, infections, cardiorespiratory failure, arrhythmias [ Time Frame: through discharge or 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Feasibility: time required to reach the target core temperature or lowest tolerated temperature, stability of patient temperature, control of rewarming, [ Time Frame: until rewarming to 36.5C has been achieved ] [ Designated as safety issue: No ]
achievement of therapeutic serum ethanol and caffeine levels, and amount of sedation needed to suppress shivering. [ Time Frame: until rewarming to 36.5C has been achieved ] [ Designated as safety issue: Yes ]
Efficacy: NIHSS < 2 at 24 hours, mRS < 2 at 3 months, NIHSS < 2 at 3 months, and length of hospital and ICU stay. [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	February 2003
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-80 years
Clinical presentation of acute ischemic stroke
CT scan compatible with acute ischemic stroke.
Time to caffeinol treatment < 240 minutes from stroke onset.
Time to hypothermia initiation < 300 minutes from stroke onset.
Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut)
NIHSS > 8 at time of each treatment.
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 < 8 at time of each treatment.
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:
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 GI bleeding
8. Impaired renal function with creatinine clearance, 50 ml/min
Intracerebral / intraventricular hemorrhage
SBP > 210 or < 100; DBP > 100 or < 50 mmHg
Severe coagulopathy
Pregnancy
Use of MAOI, SSRI or TCA within the preceding 2 weeks
Known history of epilepsy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299416

Contacts

Contact: James C. Grotta, MD	713-500-7088	james.c.grotta@uth.tmc.edu
Contact: Mary Jane Hess, RN/BSN	713-500-7078	Mary.Jane.Hess@uth.tmc.edu

Locations

United States, Texas
Memorial Hermann Hospital - Medical Center	Recruiting
Houston, Texas, United States, 77030
Contact: James C. Grotta, MD 713-500-4088 james.c.grotta@uth.tmc.edu

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

Principal Investigator:

James C. Grotta, MD

The University of Texas Health Science Center, Houston

More Information

Introduction of the staff and facility on the stroke team, types of strokes, treatment, risk factors, recovery clinical trials, and contact information. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	UT- Houston Health Science Center, Department of Neurology ( James C. Grotta, MD- )
Study ID Numbers:	HSC- MS-02-188, P50NS44277 project #1
Study First Received:	March 2, 2006
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00299416
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:

Stroke
Nonhemorrhagic
hypothermia

Study placed in the following topic categories:

Caffeine citrate
Signs and Symptoms
Hypothermia
Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Caffeine
Ischemia
Brain Diseases
Cerebrovascular Disorders
Ethanol

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases
Body Temperature Changes

ClinicalTrials.gov processed this record on January 16, 2009