Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): results from the pilot randomised controlled trial.
BACKGROUND
High blood pressure (BP) during acute stroke is associated with poorer stroke outcome. Trials of treatments to lower BP have not resulted in improved outcome, but this may be because treatment commenced too late. Emergency medical service staff (paramedics) are uniquely placed to administer early treatment; however, experience of prehospital randomised controlled trials (RCTs) is very limited.


METHODS
We conducted a pilot RCT to determine the feasibility of a definitive prehospital BP-lowering RCT in acute stroke. Paramedics were trained to identify, consent and deliver a first dose of lisinopril or placebo to adults with suspected stroke and hypertension while responding to the emergency call. Further treatment continued in hospital. Study eligibility, recruitment rate, completeness of receipt of study medication and clinical data (eg, BP) were collected to inform the design of a definitive RCT.


RESULTS
In 14 months, 14 participants (median age=73 years, median National Institute of Health Stroke Scale=4) were recruited and received the prehospital dose of medication. Median time from stroke onset (as assessed by paramedic) to treatment was 70 min. Four participants completed 7 days of study treatment. Of ambulance transported suspected stroke patients, 1% were both study eligible and attended by a PIL-FAST paramedic.


CONCLUSIONS
It is possible to conduct a paramedic initiated double-blind RCT of a treatment for acute stroke. However, to perform a definitive RCT in a reasonable timescale, a large number of trained paramedics across several ambulance services would be needed to recruit the number of patients likely to be required.


BACKGROUND
http://www.clinicaltrials.gov. Unique identifier: NCT01066572.
Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, UK.
Lisa
L
Shaw
Stroke Medicine, Northumbria Healthcare NHS Foundation Trust, Wansbeck General Hospital, Ashington, Northumberland, UK Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Christopher
C
Price
Research and Development Department, North East Ambulance Service NHS Trust, Newcastle upon Tyne, UK.
Sally
S
McLure
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Denise
D
Howel
Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
Elaine
E
McColl
Research and Development Department, North East Ambulance Service NHS Trust, Newcastle upon Tyne, UK.
Paul
P
Younger
Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, UK Stroke Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Gary A
GA
Ford
D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D061345:Early Medical Intervention / Q000379:methods*; D004632:Emergency Medical Services / Q000379:methods*; D004634:Emergency Medical Technicians; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D017706:Lisinopril / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D017706:Lisinopril
Paramedics, Clinical Management; Prehospital Care, Clinical Management; Research, Clinical; Stroke