Caffeinol Hypothermia Protocol - Full Text View

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 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia

Resource links provided by NLM:

MedlinePlus related topics: Caffeine Hypothermia

U.S. FDA Resources

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

Primary Outcome Measures:

Number of Participants With Symptomatic Intracerebral Hemorrhage [ Time Frame: from pre-dosage to 90 day followup ] [ Designated as safety issue: Yes ]
Symptomatic intracerebral hemorrhages were measured by a full NIHSS(National Institute of Health Stroke Scale) prior to caffeinol & hypothermia,at the end of hypothermia & rewarming, 24 hrs after stroke onset, daily during hospitalization,& at the 90 day follow-up visit. In addition, modified NIHSS were done hourly during the 24 hr hypothermia period & 12 hr rewarming period. At the end of rewarming an MRI was obtained to verify if hemorrhages or neurologic deteriorations were present.NIHSS scores severity of stroke on 11 items;more points given for greater deficiencies(range 0-42,0=normal)
Number of Participants With Catheter Related Complications During Hypothermia & Rewarming [ Time Frame: over 36 hour period ] [ Designated as safety issue: Yes ]
Catheter-related complications assessed whether participants had bleeding (major hemorrhaging) that required a blood transfusion, this was determined by labs. Participants were monitored for infections every hour during vital signs in the 24 hour hypothermia phase and 12 hour rewarming phase.
Number of Participants With Cardiorespiratory Failure [ Time Frame: every 30 minutes during hypothermia induction ] [ Designated as safety issue: Yes ]
The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.

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: rewarming over 12 hours until 36.5C has been achieved ] [ Designated as safety issue: No ]
Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.
Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering. [ Time Frame: rewarming over 12 hours until 36.5C has been achieved ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
NIHSS score of ≤ 2 24 hours after stroke onset modified Rankin Scale (mRS) < 2 at 90 day followup NIHSS score of ≤ 2 at daily duration of hospitalization and ICU stay and 90 day follow up.

Enrollment:	30
Study Start Date:	February 2003
Study Completion Date:	August 2009
Primary Completion Date:	January 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:	No

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 < 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)
National Institutes of Health Stroke Scale (NIHSS) > 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 < 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 gastrointestinal (GI) bleeding
8. Impaired renal function with creatinine clearance, 50 ml/min
Intracerebral / intraventricular hemorrhage
Systolic blood pressure (SBP) > 210 or < 100; diastolic blood pressure (DBP) > 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.

Contacts and Locations

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

Locations

United States, Texas
Memorial Hermann Hospital - Medical Center
Houston, Texas, United States, 77030

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

Additional 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

No publications provided

Responsible Party:	James C. Grotta, MD-, UT- Houston Health Science Center, Department of Neurology
ClinicalTrials.gov Identifier:	NCT00299416 History of Changes
Other Study ID Numbers:	HSC- MS-02-188, P50NS44277 project #1
Study First Received:	March 2, 2006
Results First Received:	August 16, 2010
Last Updated:	April 5, 2011
Health Authority:	United States: Food and Drug Administration

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

Stroke
Nonhemorrhagic
hypothermia

Additional relevant MeSH terms:

Hypothermia
Ischemia
Stroke
Cerebral Infarction
Body Temperature Changes
Signs and Symptoms
Pathologic Processes
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 23, 2013