Article Text

other Versions

PDF
Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): results from the pilot randomised controlled trial
  1. Lisa Shaw1,
  2. Christopher Price2,3,
  3. Sally McLure4,
  4. Denise Howel3,
  5. Elaine McColl3,
  6. Paul Younger4,
  7. Gary A Ford1,5
  1. 1Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, UK
  2. 2Stroke Medicine, Northumbria Healthcare NHS Foundation Trust, Wansbeck General Hospital, Ashington, Northumberland, UK
  3. 3Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK
  4. 4Research and Development Department, North East Ambulance Service NHS Trust, Newcastle upon Tyne, UK
  5. 5Stroke Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK
  1. Correspondence to Professor Gary A Ford, The Medical School, Newcastle University, 3rd floor William Leech Building, Newcastle upon Tyne NE1 4LP, UK; G.A.Ford{at}newcastle.ac.uk, gary.ford{at}ncl.ac.uk

Abstract

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.

Clinical trial registration http://www.clinicaltrials.gov. Unique identifier: NCT01066572.

  • Paramedics, Clinical Management
  • Prehospital Care, Clinical Management
  • Research, Clinical
  • Stroke

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.