PHANTOM-S: the prehospital acute neurological therapy and optimization of medical care in stroke patients - study

Abstract

Rationale: Time from symptom onset to treatment is closely associated with the effectiveness of intravenous thrombolysis in acute ischemic stroke patients. Hospitals are encouraged to take every effort to shorten delay of treatment. Despite combined efforts to streamline procedures in hospitals to provide treatment as soon as possible, most patients receive tissue plasminogen activator with considerable delay and very few of them within 90 mins. Germany has an internationally acknowledged prehospital emergency care system with specially trained doctors on ambulances. We developed an ambulance equipped with a Computed Tomography (CT) scanner, point-of-care laboratory, teleradiological support, and an emergency-trained neurologist on board. In the Pre-Hospital Acute Neurological Therapy and Optimization of Medical care in Stroke Patients study, we aim at a reduction of the current alarm-to-needle time by prehospital use of tissue plasminogen activator in an ambulance.

Aims: We hypothesized that compared with regular care, we will reduce alarm-to-needle time by a minimum of 20 mins by implementation of the stroke emergency mobile unit.

Design: Prospective study comparing randomly allocated periods with and without stroke emergency mobile unit availability.

Study outcomes: Primary end point of the study is alarm-to-needle time. Secondary outcomes include thrombolysis treatment rates, modified Rankin scale after three-months, and alarm-to-imaging or alarm-to-laboratory time; safety aspects to be evaluated are mortality and rates of (symptomatic) intracerebral hemorrhage.