Caffeinol Hypothermia Protocol

NCT00299416 | Completed Phase 1 Results DMC

• 2 other identifiers: HSC- MS-02-188P50NS44277 project #1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke; Nonhemorrhagic; hypothermia

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Symptomatic Intracerebral Hemorrhage

  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)

  from pre-dosage to 90 day followup

• Number of Participants With Catheter Related Complications During Hypothermia & Rewarming

  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.

  over 36 hour period

• Number of Participants With Cardiorespiratory Failure

  The possibility of cardiorespiratory failure was monitored every 30 minutes during the 24 hour hypothermia period based on vitals signs and oxygen saturation.

  every 30 minutes during hypothermia induction

Secondary Outcomes (3)

• Feasibility: Time Required to Reach the Target Core Temperature or Lowest Tolerated Temperature, Stability of Patient Temperature, Control of Rewarming,

  rewarming over 12 hours until 36.5C has been achieved

• Achievement of Therapeutic Serum Ethanol and Caffeine Levels, and Amount of Sedation Needed to Suppress Shivering.

  rewarming over 12 hours until 36.5C has been achieved

• 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.

  90 days

Interventions

Caffeinol DRUG

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

hypothermia PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• End-stage cardiomyopathy
• Uncompensated or clinically significant arrhythmia
• Myopathy
• Liver disease
• History of pelvic or abdominal mass likely to compress inferior vena cava.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital - Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Hypothermia

Interventions

caffeinol

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: James C. Grotta, MD
• Organization: UT-Houston Health Science Center, Department of Neurology

james.c.grotta@uth.tmc.edu

713-500-7088

Study Officials

• James C. Grotta, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 6, 2006
• Study Start: February 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: August 1, 2009
• Last Updated: May 3, 2011
• Results First Posted: May 3, 2011

Record last verified: 2011-04

Locations

US (1)