Thrombolysis in Acute Ischaemic Stroke
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Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) Thrombolysis in acute ischaemic stroke – Assessment and eligibility for IV Alteplase Lead Author: Dr Chris Douglass; Consultant Neurologist Additional author(s) Dr Adrian Parry-Jones; Consultant Neurologist Dr Rekha Siripurapu; Consultant Neuroradiologists Professor Craig J Smith; Consultant Stroke Physician Division/ Department:: Stroke Services, Manchester Centre for Clinical Neurosciences Applies to: (Please delete) Salford Royal Care Organisation Approving Committee MNARC Date approved: 09/07/2019 Expiry date: July 2022 Contents Contents Section Page 1 Overview 3 2 Scope & Associated Documents 3 3 Background 4 4 What is new in this version? 4 5 Policy 5 5.1 Initial urgent clinical assessment 5 5.2 Urgent brain imaging 7 5.3 Thrombolysis checklist 8 5.4 Information giving 11 6 Roles and responsibilities 12 7 Monitoring document effectiveness 12 8 Abbreviations and definitions 13 9 References 13 10 Appendices Patient information sheet 16 Thrombolysis in Children aged 16-18 18 Paediatric NIHSS 22 11 Document Control Information 29 12 Equality Impact Assessment (EqIA) screening tool 31 Thrombolysis in acute ischaemic strokes; assessment and eligibility for iv Alteplase Reference Number TWCG6(12) Version 4 Issue Date: 05/09/2019 Page 1 of 31 It is your responsibility to check on the intranet that this printed copy is the latest version Group arrangements: Salford Royal NHS Foundation Trust (SRFT) Pennine Acute Hospitals NHS Trust (PAT) 1. Overview (What is this policy about?) Thrombolysis with intravenous (iv) tissue plasminogen activator (tPA; alteplase) is a cost- effective treatment for use in selected patients within 4.5 h of acute ischaemic stroke according to eligibility criteria derived from randomised-controlled trials (RCTs) and expert consensus. The potential benefits from iv tPA are highly time-dependent (“time is brain”), meaning that focus on “door-to-needle” (DTN) and “onset-to-needle” (OTN) times is critical. As iv thrombolysis is not without potentially serious side effects, appropriate selection of patients for treatment based on rapid assessment of the potential risks/benefits is of vital importance. The purpose of this policy is to consolidate best evidence-based guidance to inform timely, safe and appropriate use of iv tPA in acute ischaemic stroke at SRFT. This policy describes the processes involved in urgent assessment of eligibility for iv tPA and provides guidance on provision of standardised information about risks and benefits of thrombolysis to patients and their families. There are currently no recommended decision tools for individualised prediction of risk-benefit when considering thrombolysis with iv tPA in clinical practice 2. Scope (Where will this document be used?) SRFT is committed to high-quality care for patients with stroke. SRFT is the Comprehensive Stroke Centre (CSC) for the Greater Manchester Conurbation, providing a 24/7 iv thrombolysis service. This policy incorporates best evidence-based and consensus guidance and the local systems and processes relevant to delivering iv tPA safely and quickly. It describes the processes involved in urgent assessment of eligibility and provides guidance on provision of standardised information about risks and benefits of thrombolysis to patients and their families. Associated Documents: http://guidance.nice.org.uk/TA264/Guidance/pdf/English http://www.rcplondon.ac.uk/sites/default/files/national-clinical-guidelines-for-stroke-fourth- edition.pdf https://www.rcpch.ac.uk/sites/default/files/2018-07/2017_stroke_in_childhood_- _guideline_final_3.6.pdf Thrombolysis in acute ischaemic stroke – awareness and management of angioedema: TC 3 (09) – Issue No: 4 http://intranet.srht.nhs.uk/policies-resources/trust-policy-documents/trust-wide- clinical/gen/tc309/ Thrombolysis in acute ischaemic strokes; assessment and eligibility for iv Alteplase Reference Number TWCG6(12) Version 4 Issue Date: 05/09/2019 Page 2 of 31 It is your responsibility to check on the intranet that this printed copy is the latest version Acute Stroke - Management of Hyperglycaemia: TWCG09(14) - Issue No 2 - Acute Stroke management of Hyperglycaemia http://intranet/policies-resources/trust-policy-documents/trust-wide-clinical/gen/twcg0914/ Thrombolysis in acute ischaemic stroke – management of acutely elevated blood pressure: TC 10 (10) – Issue No: 3 http://intranet.srht.nhs.uk/policies-resources/trust-policy-documents/trust-wide- clinical/gen/tc1010/ 3. Background Thrombolysis with iv tPA is an evidence-based and cost-effective therapy for ischaemic stroke in selected patients presenting within 4.5 hours of symptom onset.1,2,3 iv tPA is safe and effective when given up to 4.5 hours from symptom onset,4 and international thrombolysis audit registries confirm the safety and efficacy profile of iv tPA administered up to 4.5 hours in clinical practice, when patients are selected according to defined eligibility criteria.5 4. What is new in this version? The eligibility criteria for iv tPA have been revised in line with recent consensus appraisal of the available literature,6 and consensus reached within the Greater Manchester Operational Delivery Network (ODN). The thrombolysis checklist (Table 3) has been amended accordingly. The upper age limit of 80 y has been removed from the CTA protocol as there is no justification in excluding those >80 y from consideration of thrombectomy 7 The lower age limit of 18 has been reduced to 16 following the Royal College of Paediatrics and Child Health Guidelines of May 2017. 17 The patient and relative information has been updated in line with most recent data concerning risks and benefits of iv tPA Thrombolysis in acute ischaemic strokes; assessment and eligibility for iv Alteplase Reference Number TWCG6(12) Version 4 Issue Date: 05/09/2019 Page 3 of 31 It is your responsibility to check on the intranet that this printed copy is the latest version 5. Policy 5.1 Initial urgent clinical assessment FAST 8 positive courtesy “red” call received via NWAS, activating acute stroke assessment team baton pagers Patients self-presenting to A&E who are FAST positive and have an onset time within 4 hours will be reviewed by the Emergency Department (ED) consultant who will put a 2222 call to switchboard for immediate Stroke Team response via assessment team baton pagers Acute stroke assessment nurse and duty registrar/ advanced nurse practitioner (ANP)/ senior Dr attend (ED) as soon as possible Urgent observations in ED: o Airway integrity o Respiratory rate and oxygen saturations o Circulation (heart rate and blood pressure) o Glasgow Coma Scale (GCS) o BM stix; cannula o Urgent blood tests o 12-lead ECG History & Examination to include: o drug history 9 o pre-stroke mRS (modified Rankin Scale) score (Table 1) o neurological examination 10 o NIHSS (National Institutes of Health Stroke Scale) score (Table 2) Thrombolysis in acute ischaemic strokes; assessment and eligibility for iv Alteplase Reference Number TWCG6(12) Version 4 Issue Date: 05/09/2019 Page 4 of 31 It is your responsibility to check on the intranet that this printed copy is the latest version Table 1: Modified Rankin score (4 weeks before current stroke presentation) 0 No symptoms at all. 1 No significant disability despite symptoms. Able to carry out all usual duties and activities. Slight disability: unable to carry out all previous activities, but able to look after own affairs without 2 assistance. 3 Moderate disability: requiring some help but able to walk without assistance. Moderately severe disability: unable to walk without assistance and unable to attend to own bodily 4 needs without assistance. 5 Severe disability: bedridden, incontinent, and requiring constant nursing care and attention. Table 2: NIHSS score Tested item Item Response and score 1A Level of consciousness 0-alert 1-drowsy 2-obtunded 3-coma/unresponsive 1B Orientation questions 0-answers both correctly 1-answers one correctly 2-answers neither correctly 1C Response to commands 0-performs both corerctly 1-perorms one correctly 2-performs neither correctly 2 Best gaze 0-normal horizontal movements 1-partial gaze palsy 2- complete gaze palsy 3 Visual fields 0-no visual field defect 1-partial hemianopia 2-complete hemianopia 3-bilateral hemianopia 4 Facial palsy 0-normal 1-minor facial weakness 2-partial facial weakness 3-complete unilateral palsy 5 Motor function arm 0-no drift a – left 1-drift before 5s b – right 2-falls before 10s 3-no effort against gravity 4-no movement 6 Motor function leg 0-no drift a – left 1-drift before 5s b – right 2-falls before 5s 3-no effort against gravity 4-no movement 7 Limb ataxia 0-no ataxia 1-ataxia in 1 limb 2-ataxia in 2 limbs 8 Sensory 0-normal 1-mild/moderate sensory loss 2-sever/total sensory loss 9 Best language 0-normal 1-mild/moderate aphasia 2-severe aphasia 3mute or global aphasia 10 Dysarthria 0-normal 1-mild/moderate dysarthria 2-severe dysarthria 11 Extinction/inattention 0-normal 1-mild loss (one modality) 2-severe loss (2 modalities) Thrombolysis in acute ischaemic strokes; assessment and eligibility for iv Alteplase Reference Number TWCG6(12) Version 4 Issue Date: 05/09/2019 Page 5 of 31 It is your responsibility to check on the intranet that this printed copy is the latest version 5.2 Urgent brain imaging Plain CT brain scan next available slot, 24h/ day Proceed directly to CTA in selected patients (Category 1A) as per protocol (Figure 1) where appropriate without delaying IV treatment Before proceeding with thrombolysis, the imaging must be reviewed by an appropriately trained individual. This may be a consultant stroke physician/ neurologist or trainee. All imaging will be reviewed by the duty radiology SpR, or the teleradiology service overnight, and reported on EPR. Consider the need for intra-arterial intervention (see SRFT Emergency intra-arterial (IA) intervention in acute ischaemic stroke).11 Figure 1: Hyperacute Stroke CT/CTA Protocol Patients being considered for iv tPA require an urgent plain CT (next available slot).