Field Administration of Stroke Therapy-Blood Pressure Lowering

• Status: Terminated
• Trial end date: 2013-12-09
• Target enrollment: 0
• Participant gender: All

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 patients. The primary objective of the study is to evaluate the feasibility, safety, and physiologic efficacy of field-initiated glyceryl trinitrate in achieving modest reduction of blood pressure. Patients with acute stroke will be identified in the field by paramedics who have received training in basic and advanced cardiac life support, stroke recognition, and specific procedures relevant to the proposed study. Physician-investigators will obtain informed consent for each subject for study entry after cellular phone contact with paramedics. Paramedics will initiate antihypertensive treatment by applying transdermal GTN patch in the first two dose-tiers, and administering a single sublingual GTN metered spray followed by application of the transdermal system in the last dose tier. The sites involved in the study will be emergency medical services rescue ambulances and 8 receiving Stroke Center hospitals in Orange County, California, USA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Nitroglycerin

Criteria

Inclusion Criteria:

1. Suspected stroke identified with Los Angeles Prehospital Stroke Screen

2. Age 40-80, inclusive

3. Last known well time within 2 hours of treatment initiation

4. Deficit present for > 15 minutes

5. Systolic blood pressure ≥180

Exclusion Criteria:

1. Coma

2. Rapidly improving neurologic deficit

3. Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations

4. Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or > 24)

5. Major head trauma in the last 24 hours

6. Recent stroke within prior 30 days

7. Use of erectile dysfunction therapies in the previous 12 hours

8. Use of type V phosphodiesterase inhibitors

9. Patient unable to give informed consent and no available legally authorized representative (LAR) to provide informed consent