NCT00299416|CompletedPhase 1/2ResultsDMC
Caffeinol Hypothermia Protocol
Combined Neuroprotective Modalities Coupled With Thrombolysis in Acute Ischemic Stroke: A Pilot Study of Caffeinol and Mild Hypothermia
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Sponsor study identifier
Secondary identifiers
interventional
30
1 country
1
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2009
Actual (reported)Study Completion
August 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
March 2, 2006
Actual (reported)March 6, 2006
Actual (reported)January 2009
Actual (reported)August 2009
Actual (reported)May 3, 2011
Actual (reported)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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Memorial Hermann Hospital - Medical Center
Houston, Texas, 77030, United States
James C. Grotta, MD
The University of Texas Health Science Center, Houston
30 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2006
First Posted
March 6, 2006
Study Start
February 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2009
Actual (reported)Study Completion
August 2009
Actual (reported)Last Updated
May 3, 2011
Results First Posted
May 3, 2011
Record last verified: 2011-04
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Source: ClinicalTrials.gov.
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