AN Siriwardena

C Delcourt

C Geeganage

Christopher Price

Crash Trial Management Group

Denise Howel

Department of Health

Department of Health Scientific Development and Bioethics Division

EC Sandset

Elaine McColl

FI Mahoney

GA Lancaster

Gary A Ford

GM Sare

H Brazier

H Snooks

J Leonardi-Bee

JC van Swieten

JF Potter

JL Saver

L Thabane

Lisa Shaw

LJ Morrison

M Reinhard

M Willmot

Medical Care Research Unit University of Sheffield

ML Flaherty

N Ahmed

Sally McLure

T Brott

W Hacke

Trials

English

PubMed

Shaw, Lisa

Price, Christopher

McLure, Sally

Howel, Denise

McColl, Elaine

Ford, Gary A.

Ambulance Research Repository (AMBER)

Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial

Abstract
          
            Background
            High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics). However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke.
          
          
            Methods
            Trial Design: Double blind parallel group external pilot randomised controlled trial.
            Setting: Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals.
            Participants: Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset) and hypertension (systolic BP&gt;160 mmHg).
            Intervention: Lisinopril 5-10 mg (intervention group), matched placebo (control group), daily for 7 days.
            Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics.
            Outcomes: Study feasibility (recruitment rate, compliance with data collection) and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function).
          
          
            Discussion
            This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke.
          
          
            Trial Registration
            EudraCT: 2010-019180-10
            ClinicalTrials.gov: NCT01066572
            
            ISRCTN: 54540667
            
          </jats:sec

Crossref

Shaw, L.

International Journal of Stroke

Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): first results from the pilot randomised controlled trial

Springer - Publisher Connector

A tutorial on pilot studies: the what, why and how.

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http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3141530

Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial

Abstract

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Ambulance Research Repository (AMBER)

Springer - Publisher Connector

Ambulance Research Repository (AMBER)