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Completed

NCT Number: NCT00299416

Caffeinol Hypothermia Protocol

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.

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Key information

Conditions

Acute Ischemic Stroke Body Temperature Changes Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypothermia Ischemic Stroke Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Memorial Hermann Hospital - Medical Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Participants With Symptomatic Intracerebral Hemorrhage

    Time frame: from pre-dosage to 90 day followup

    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)

  2. Number of Participants With Catheter Related Complications During Hypothermia & Rewarming

    Time frame: over 36 hour period

    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.

  3. Number of Participants With Cardiorespiratory Failure

    Time frame: every 30 minutes during hypothermia induction

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

Secondary outcomes

  1. 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

    Hypothermia will be maintained for 24 hours, afterward, the patient will be rewarmed, gradually, over 12 hours to 36.5C.

  2. 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

  3. 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

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2006
Registry last updated
May 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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