Field Administration of Stroke Therapy-Blood Pressure Lowering
Status:
Terminated
Trial end date:
2013-12-09
Target enrollment:
Participant gender:
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.