Text Size

Caffeinol Hypothermia Protocol

This study has been completed.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00299416
First received: March 2, 2006
Last updated: April 5, 2011
Last verified: April 2011
History of Changes
Results First Received: August 16, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Ischemic Stroke
Interventions: Drug: Caffeinol
Procedure: hypothermia

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patient/& or family was approached by one of the investigators in the Emergency Department in order to obtain informed consent.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Open label pilot trial; Caffeinol Arm

Reporting Groups
  Description
Caffeinol Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.

Participant Flow:   Overall Study
    Caffeinol  
STARTED     30  
COMPLETED     30  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Caffeinol Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.

Baseline Measures
    Caffeinol  
Number of Participants  
[units: participants]
 		  30  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     28  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation 		  54.7  ± 15.6  
Gender  
[units: participants]
 		 
Female     18  
Male     12  
Region of Enrollment  
[units: participants]
 		 
United States     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Symptomatic Intracerebral Hemorrhage   [ Time Frame: from pre-dosage to 90 day followup ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Catheter Related Complications During Hypothermia & Rewarming   [ Time Frame: over 36 hour period ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants With Cardiorespiratory Failure   [ Time Frame: every 30 minutes during hypothermia induction ]
  Show Outcome Measure 3

4.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: James C. Grotta, MD
Organization: UT-Houston Health Science Center, Department of Neurology
phone: 713-500-7088
e-mail: james.c.grotta@uth.tmc.edu


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