Status:
TERMINATED
Field Administration of Stroke Therapy-Blood Pressure Lowering
Lead Sponsor:
University of California, Los Angeles
Conditions:
Intracerebral Hemorrhage
Ischemic Stroke
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
This is an open, pilot, dose-escalation study of glyceryl trinitrate (GTN, Nitroglycerin) administered by paramedics in the field within 2 hours of symptom onset to 45 severely hypertensive stroke pat...
Detailed Description
The central aim of this phase 2a study is to identify a regimen of paramedic initiated glyceryl trinitrate antihypertensive therapy in acute stroke patients that is safe, is technically effective in m...
Eligibility Criteria
Inclusion
- Suspected stroke identified with Los Angeles Prehospital Stroke Screen
- Age 40-80, inclusive
- Last known well time within 2 hours of treatment initiation
- Deficit present for \> 15 minutes
- Systolic blood pressure ≥180
Exclusion
- Coma
- Rapidly improving neurologic deficit
- Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
- Severe respiratory distress (O2 sat \< 90% or respiratory rate \< 12 or \> 24)
- Major head trauma in the last 24 hours
- Recent stroke within prior 30 days
- Use of erectile dysfunction therapies in the previous 12 hours
- Use of type V phosphodiesterase inhibitors
- Patient unable to give informed consent and no available legally authorized representative (LAR) to provide informed consent
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01811693
Start Date
April 1 2013
End Date
December 9 2013
Last Update
October 29 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Alamitos Medical Center
Los Alamitos, California, United States, 90720
2
FAST-MAG Clinical Trial Coordinating Center
Los Angeles, California, United States, 90024