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NCT00299416 · ClinicalTrials.gov registry record · Phase 1
Caffeinol Hypothermia Protocol
A Phase 1 study of Acute Ischemic Stroke, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT00299416: Completed Phase 1 study of Acute Ischemic Stroke, sponsored by The University of Texas Health Science Center, Houston.
NCT00299416 is a Phase 1 study of Acute Ischemic Stroke that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 30 participants, below the 351-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299416, a Phase 1 study of Acute Ischemic Stroke, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Caffeinol
- PROCEDURE hypothermia
Study Locations (1)
Texas
- Memorial Hermann Hospital - Medical Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2003-02 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
What the finished NCT00299416 record still lists
NCT00299416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 351-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which Caffeinol is the first listed.
NCT00299416 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00299416 about?
NCT00299416 is a clinical study titled "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.
What is the current status of trial NCT00299416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2003-02. Estimated completion is 2009-08.
What conditions does trial NCT00299416 study?
This clinical trial studies the following conditions: Acute Ischemic Stroke.
What interventions are being tested in trial NCT00299416?
The interventions under investigation include: Caffeinol (DRUG), hypothermia (PROCEDURE).
Who is sponsoring clinical trial NCT00299416?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00299416 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00299416's enrollment target sits among peer trials
30 24th of 25 higher than 2 of 25 other Acute Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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