Abstract
BackgroundHigh 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.MethodsTrial 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>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).DiscussionThis 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 RegistrationEudraCT: 2010-019180-10ClinicalTrials.gov: NCT01066572ISRCTN: 54540667
Highlights
High blood pressure during acute stroke is associated with poorer stroke outcome
Acute stroke treatments are known to be time dependent due to the rapid speed at which neuronal injury occurs following cerebral hypoxia and oedema [9]. This has been very clearly demonstrated by the pooled data from trials assessing the effects of intravenous thrombolysis on acute ischaemic stroke where every minute of delay resulted in a reduced chance of a better outcome until 4.5 - 6 hours after symptom onset[10]
Current hospital based trials of blood pressure lowering following cerebral haemorrhage have recognised the importance of treatment timing and are being performed with time windows of 6 hours or less [11,12]
Summary
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. Acute stroke treatments are known to be time dependent due to the rapid speed at which neuronal injury occurs following cerebral hypoxia and oedema [9]. This has been very clearly demonstrated by the pooled data from trials assessing the effects of intravenous thrombolysis on acute ischaemic stroke where every minute of delay resulted in a reduced chance of a better outcome until 4.5 - 6 hours after symptom onset[10]. Current hospital based trials of blood pressure lowering following cerebral haemorrhage have recognised the importance of treatment timing and are being performed with time windows of 6 hours or less [11,12]
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
