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Caffeinol Hypothermia Protocol

NCT00299416 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-05-03

Study results available
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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

Interventions

DRUG

Caffeinol

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

PROCEDURE

hypothermia

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • James C. Grotta, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2009-01-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299416 on ClinicalTrials.gov