ࡱ> a Rbjbjzz .P\P\Ir r :::NNN8R,N2mV~lllB B B ul>llllll$o>rfl::# ":#:#lllH.H.H.:#l8lulH.:#ulH.H. b"gl6?-~(c6alm02m#dr)>rlgr:gB rH.T!\!B B B ll(, B B B 2m:#:#:#:#rB B B B B B B B B r > : Policy #: Issued: June 2015 Reviewed:  January 2017Revised:July 2016Section:  Acute Stroke Guideline Purpose: To provide guidance in the care of an Acute Ischemic Stroke patient Application: For all potential acute ischemic stroke patients presenting with Last Known Well less than 6 hours Exceptions: Patients who present with stroke symptoms greater than 6 hours Procedure: IV tPA Guideline: Acute Ischemic Stroke Disclaimer This protocol was developed by the Stroke Service and members of the Stroke Taskforce at Boston Medical Center and outlines the major responsibilities for the urgent evaluation and treatment of acute stroke patients who present to the ED. This information is intended to be used only as a medical and educational reference tool. It does not replace or overrule the treating physician's judgment or diagnosis. We tried to keep the information as accurate as possible and therefore disclaim any implied warranty or representation about its accuracy or appropriateness for a particular purpose. This stroke protocol is subject to change without notice. Emergency Department Stroke Care Process Measure Assessment Tool ActivityTime TargetsDoor to notification of Acute Stroke Team (AST), i.e., making the call to the team*within 5 minutes of arrivalTime from notification of AST to response of team member by phone or at patient bedside to assess patient*within 5 minutes of being calledDoor to CT scan or MRI scan within 25 minutes Door to CT result within 45 minutes Door to completion of chest X-Ray and interpretationwithin 45 minutes Door completion of ECG and interpretationwithin 45 minutes Door to completion of labs and results/interpretationwithin 30 minutes Results (labs, CT) to tPA decision time*Within 10 minutesED door-to-needle time for IV thrombolytic (tPA) treatmentwithin 45 minutes Time from order of neurosurgical evaluation to start of evaluation; includes transfer to another hospital for such evaluation, if applicablewithin 2 hours of being deemed clinically necessaryNeurosurgical interventionas needed urgently* DPH stroke care recommendations modified for BMC. NOTE: Complete tPA consent form to patients who will receive tPA in the 3-4.5 hour window and give information sheet to patient. Intravenous tPA in Acute Ischemic Stroke Approved FDA use for LESS than 3.0 hours from initial symptoms Off-label use for 3 to 4.5 hours (see additional warnings below requires consent) A. Indications New symptomatic ischemic stroke with clearly defined Last Known Well < 3 hours Age 18 or more Patient evaluated by in-house neurology fellow or resident, and tPA approved by stroke fellow or ED attending (via phone or in person) B. Contraindications CT scan findings of intracranial hemorrhage or major acute infarct (> 1/3 cerebral hemisphere) Suspicion of subarachnoid hemorrhage (even if head CT is negative for hemorrhage) Significant head trauma or prior stroke in previous 3 months Intracranial or intra-spinal surgery within the prior 3 months History of previous intracranial hemorrhage or large (>10mm) brain aneurysm, vascular malformation or intraparenchymal brain tumor Arterial puncture at non-compressible site in previous 7 days Known bleeding diathesis OR Current use of oral anticoagulants with INR > 1.7 or PT > 15 seconds Use of heparin within 48 hours preceding onset of stroke AND prolonged aPTT at time of presentation. Low molecular weight heparin use (i.e.- Lovenox) in the past 24 hours. If suspected abnormal platelet counts and platelets <100,000 Active internal hemorrhage Novel oral anticoagulant use in the past 48 hours. If last dose >48 hours, confirm normal renal function [creatinine clearance >50 mL/min] and normal coagulation [aPTT, INR, platelet count, thrombin time or appropriate factor Xa activity assays] before tPA administration. See Addendum, A. Persistent systolic BP >185 mm Hg or diastolic BP >110 mm Hg despite treatment. Patients treated within 3-4.5 hour window warnings Age > 80 Any anticoagulant use (even if INR < 1.7) NIHSSS > 25 History of stroke AND diabetes C. Warnings (risks must be weighed against anticipated benefits) MI within last 3 months (with normal TTE) Current use of oral anticoagulants with INR > 1.5 or PT > 15 seconds Major surgery or serious trauma within previous 2 weeks, consider surgical site hemorrhage risk Non-disabling, or rapidly-improving symptoms (see Addendum, B.) High likelihood of left heart thrombus Aortic dissection Small or moderate-sized intracranial aneurysm (<10 mm) or vascular malformation. Consider for severe neurologic deficits and disabling symptoms. Severe neurological deficit (NIH stroke scale score >22) Seizure at symptom onset, particularly with head trauma History of IVDU and/or suspicion for endocarditis Tox-screen positive for ETOH, cocaine, opiates, or amphetamines (if available, but should not delay tPA protocol) Subacute bacterial endocarditis Acute pericarditis History of hemorrhagic diabetic retinopathy Significant hepatic dysfunction with abnormal INR Pregnancy Sickle cell disease Internal hemorrhage (e.g., GI or urinary tract) < 3 weeks Blood glucose < 50 mg/dL D. Not a contraindication Current aspirin, NSAID or antiplatelet drugs (dipyridamole, ticlopidine, clopidogrel) History of PUD (not currently active [>3 months]) E. For those patients presenting with a suspected stroke to the Emergency Room: EMT/Triage: alert EM-MD and stroke resident (pager 3278) Activate Level 2 (P2) of Stroke Alert pager Patient is transferred/assigned to the Trauma Room or Acute Side EM/MD: ORDER STAT HEAD-CT (non-contrast enhanced) AND STAT STROKE-CONSULT [if NIHSS > 6, order STAT CTA for patients who could be candidates to bridge from iv tPA to intra-arterial intervention- DO NOT DELAY tPA TO COMPLETE THE CTA] If the patient has a significant neurological deficit (i.e. NIHSS > 6) and/or CTA demonstrates proximal vessel occlusion, the neurointerventional team should be activated early (pager 2645 or COIL) RN/MD: Establish 2 IV sites, including stat 18 gauge antecubital IV for CTA (ideally on right), start 0.9% NS 250- 500 cc bolus followed by NS @ 80 cc/hour Cardiac monitor, pulse oximeter, continuous vital signs 12 lead EKG and CXR after CT unless experiencing chest pain Clinical evaluation for active illicit drug use (toxicology screen) or ETOH intoxication Obtain patient weight early Notify pharmacy early regarding potential tPA preparation. STAT Labs: PTT, INR, CBC (without diff.), electrolytes, BUN, creatinine, CK & troponin, glucose, type & hold. Call Hematology lab to notify this is a stroke patient, place stroke stickers on tubes. tPA is approved by stroke attending or ED attending and Stroke Fellow. ED attending MUST be notified if tPA is going to be given Admit to ICU For those patients with a suspected stroke while hospitalized: Activate the inpatient Code Stroke, alert stroke resident (pager 3278); Page Rapid Response Team. Stat bedside glucose Stat Head CT, CTA if NIHSS > 6 Place order for IV tPA- notify Pharmacy Order stat blood tests: PTT, INR, CBC (without diff.), electrolytes, BUN, creatinine, CK & troponin, glucose, type and hold tPA approved by stroke attending. tPA can be given by the Stroke Service, CCRN, ICU nurse, or ED nurse. Transfer patient to ICU RN/MD (as above) Establish 2 IV sites, including stat 18 gauge antecubital for CTA, start 0.9% NS 250 cc bolus followed by NS @ at 80 cc/hour Cardiac monitor, pulse oximeter, monitor vital signs If patient is candidate for IA intervention, IR attending will consider foley catheter G. Once tPA has been started Do not perform for 24 hours post tPA unless procedure is life-saving: Arterial or central venous punctures/lines, IM injections, nasogastric tubes, Foley catheters Place the patient on anticoagulation precautions until 24 hours after the infusion Do not give any antithrombotic drugs (including heparin, warfarin, aspirin, clopidogrel, dipyridamole, ticlopidine, or NSAIDS) x 24hrs H. Administration The stroke fellow will utilize a phone consultation with the stroke attending prior to administering IV tPA Administer tPA in monitored setting (unit bed or emergency room) Bolus may be given in CT and on floor for in-house strokes as long as critical care or resource nurse present Mix a 100 mg tPA vial with 100 cc NS- 1cc=1mg Estimate total body weight (if not measured on admission) Calculate TOTAL tPA DOSE: 0.9 mg per kg (not to exceed 90 mg total dose) Give 10% as IV bolus over 1 minute Give other 90% as IV infusion over 60 minutes infuse 50 cc NS after dose to flush medication Vital signs and neuro-checks at least every 15 min for first 2 hours, including NIHSS scores, which must be documented in Epic note Treat systolic BP if it rises to >180 mm Hg or diastolic BP >105 mm Hg for more than 15 minutes Pause infusion while BP is being controlled. Avoid BP decrease <160/ 85 mm Hg tPA Dosing (estimated weight) Estimated Weight (lbs)Conversion to Kilograms (Kg)Total iv t-PA Dose (mg) at 0.9 mg/kgt-PA Bolus (mg) *10% of total*t-PA Bolus (ml)Discard Dose t-PA (Not for infusion)Infusion Dose (mg)Infusion Rate (ml/hr)220+100.090.09.09.010.081.081.021095.585.98.68.614.177.377.320090.981.88.28.218.273.673.619086.477.77.87.822.370.070.018081.873.67.47.426.466.366.317077.369.57.07.030.562.662.616072.765.56.56.534.558.958.915068.261.46.16.138.655.255.214063.657.35.75.742.751.551.513059.153.25.35.346.847.947.912054.549.14.94.950.944.244.211050.045.04.54.555.040.540.510045.540.94.14.159.136.836.8 I. Monitoring: Admit to ICU and monitor patient in ICU for a minimum of 24 hours. Unless the patient is unstable, notify ED attending and bed control RN that patient should be admitted to the neurocritical care service in the neuro-ICU (ENC 3 West). The patient will be co-managed by the MICU service. Patients undergoing acute endovascular or surgical treatment will be admitted to the HAC SICU. The ED Neurology resident must sign out to the appropriate admitting ICU resident Blood pressure monitoring: During the first 24 hours after tPA, monitor BP: Every 15 minutes for 2 hours after starting the infusion, then Every 30 minutes for 6 hours, then Every 60 minutes until 24 hours after starting treatment 3 If systolic blood pressure is >180 mmHg or if diastolic blood pressure is >105 mmHg for 2 or more readings 5 to 10 minutes apart, the following is recommended: First tier intervention: Give IV labetalol 10 mg over 1 to 2 minutes. Labetalol may be repeated up to 3 doses every 10 to 20 minutes (doubling doses if needed depending on effect of preceding dose; eg. 1st dose-10mg, 2nd dose- 20mg, 3rd dose- 40mg, then consider drip) For heart rate<60/minute, use hydralazine 5-20mg intravenous over 1-2 minutes every 20-30 minutes. After second bolus, consider second line intervention Monitor blood pressure and neurologic exam every 15 minutes during treatment and observe for development of hypotension for all 3 tiers of BP interventions Second tier intervention: If 3 doses of labetalol or hydralazine bolus or 30 minutes pass without sufficient BP control, the next step should be a nicardipine drip Third tier intervention: If nicardipine drip fails, then the next step should be a labetalol drip **To avoid worsening of cerebral ischemia, target BP of 155-175/85-100. Use 0.9% NS only, as needed (avoid hypotonic solutions). Initiate fluid hydration in the ED with 250-500 cc bolus followed by 80 cc per hour, except in those patients who have a contraindication (pulmonary edema, renal failure, known CHF) 5. Further management as directed by the neurocritical care service ADDENDUM A. Considerations for patients on novel oral anticoagulants (NOACs): Rivaroxaban (Xarelto)Apixaban (Eliquis)Dabigatran (Pradaxa)Edoxaban (Savaysa)MechanismFactor Xa inhibitorFactor Xa inhibitorDirect thrombin inhibitorFactor Xa inhibitorTypical dose for Afib20mg daily5mg BID150mg BID60mg dailyOnset of action3-4 hours3-4 hours0.5-2 hours1-2 hoursHalf life5-9 hours12 hours12-17 hours10-14 hoursMonitoringAnti-factor Xa levels*Anti-factor Xa levels*aPTT*Anti-factor Xa levels*Reversal agentsConsider PCC**Consider PCC**Idarucizumab (Praxbind); dialysis; consider PCC**Consider PCC** *Limited monitoring of NOACs available by the following means: Rivaroxaban: PT and aPTT are prolonged in a dose-dependent manner with 1-4 hours after administration of rivaroxaban. Increase is short-lived and at therapeutic levels, rivaroxaban will NOT reliably elevate PT/aPTT. Antifactor Xa levels must be specifically calibrated for Factor Xa inhibitors and are assay specific. This is a send-out test that takes at least 5-6 days to result. Apixaban: PT/aPTT are insensitive. Antifactor Xa levels must be specifically calibrated for Factor Xa inhibitors and are assay specific. This is a send-out test that takes at least 5-6 days to result. Dabigatran: a normal aPTT excludes the presence of a significant amount of dabigatran but degree of aPTT isnt correlated with degree of coagulopathy (non-linear dose response curve, plateaus at higher concentrations). **There is no evidence-proven effective reversal agents for NOACs. In the setting of serious or life-threatening bleeding, PCC can be used at a dose of 50 unites/kg. Note: see BMC policy for Reversal of Anticoagulation in Adults for complete information. Rivaroxaban: Evidence suggests that PCC may be effective for reversal. Apixaban: PCC has not yet been studied for reversal of Apixaban. Dabigatran: FDA approved idarucizumab (Praxbind) to reverse anticoagulant effects. Evidence suggests that PCC is not effective for dabigatran reversal. Because dabigatran is primarily renally excreted, dialysis of 2-3 hours can remove 60% of the circulating drug. B. Considerations in patients with minor or rapidly improving symptoms (NIHSS <4) Patients with minor symptoms (NIHSS <4) may still benefit from tPA, especially if the symptoms are likely to be debilitating (complete hemianopsia, aphasia, visual or sensory extinction, weakness limiting effort against gravity, deficit considered disabling in the view of the patient or practitioner, etc.) Because time from onset of symptoms to treatment has such a powerful impact on outcome, delaying treatment with IV tPA to monitor for further improvement is not recommended. Several studies have reported that approximately 1/3 of patients who are not treated with tPA because of mild or rapidly improving stroke symptoms on hospital arrival have a poor final stroke outcome. C. Treatment of patients who sustain a hemorrhage soon after IV t-PA administration STAT Hematology consult In addition to standard labs, check fibrinogen Cryoprecipitate 10 units Consider aminocaproic acid or tranexamic acid Consider platelet transfusion (6-8 units) Consider FFP transfusion Responsibility: MD, RN, Radiologist, radiology tech, Lab, Pharmacy Forms: tPA consent, tPA information sheet, IR consent Other Related Policies: IA Stroke Protocol, References: Demaerschalk BM, et al. Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke. Stroke 2016. De Smedt A, De Raedt S, Nieboer K, De Keyser J, Brouns R. Intravenous thrombolysis with recombinant tissue plasminogen activator in a stroke patient treated with dabigatran. Cerebrovasc Dis. 2010;30:533534 Ganetsky M, Babu KM, Salhanick SD, Brown RS, Boyer EW. Dabigatran: review of pharmacology and management of bleeding complications of this novel oral anticoagulant. J Med Toxicol. 2011 Dec;7(4):281-7. Watanabe M, Siddiqui FM, Qureshi AI. Incidence and management of ischemic stroke and intracerebral hemorrhage in patients on dabigatran etexilate treatment. Neurocrit Care. 2012 Feb;16(1):203-9. Alberts M., Bernstein R., Naccarelli G., Garcia D. Using Dabigatran in Patients With Stroke A Practical Guide for Clinicians. Stroke. 2012; 43: 271-279 del Zoppo G, Saver J, Jauch EC, et al. Expansion of the Time Window for Treatment of Acute Ischemic Stroke WithIntravenous Tissue Plasminogen Activator. A Science Advisory From the American Heart Association/American StrokeAssociation. Stroke 2009; 40: 2945. De Silva DA, Manzano JJ, Chang HM, Wong MC. Reconsidering recent myocardial infarction as a contraindication for IV stroke thrombolysis. Neurology 2011;76:1838-40. Hacke W, Kaste M, Bluhmki E, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008;359:1317-29. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med 1995;333:1581-7.  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Rost%20NS%22%5BAuthor%5D" Rost NS,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Masrur%20S%22%5BAuthor%5D" Masrur S,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Pervez%20MA%22%5BAuthor%5D" Pervez MA,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Viswanathan%20A%22%5BAuthor%5D" Viswanathan A,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Schwamm%20LH%22%5BAuthor%5D" Schwamm LH. Unsuspected coagulopathy rarely prevents IV thrombolysis in acute ischemic stroke.  HYPERLINK "javascript:AL_get(this,%20'jour',%20'Neurology.');" \o "Neurology." Neurology. 2009 Dec 8;73(23):1957-62. Epub 2009 Nov 25.  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Selim%20M%22%5BAuthor%5D" Selim M,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Kumar%20S%22%5BAuthor%5D" Kumar S,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Fink%20J%22%5BAuthor%5D" Fink J,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Schlaug%20G%22%5BAuthor%5D" Schlaug G,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Caplan%20LR%22%5BAuthor%5D" Caplan LR,  HYPERLINK "http://www.ncbi.nlm.nih.gov/pubmed?term=%22Linfante%20I%22%5BAuthor%5D" Linfante I. Seizure at stroke onset: should it be an absolute contraindication to thrombolysis?  HYPERLINK "javascript:AL_get(this,%20'jour',%20'Cerebrovasc%20Dis.');" \o "Cerebrovascular diseases (Basel, Switzerland)." Cerebrovasc Dis. 2002;14(1):54-7. Kubitza et al. Eur J Clin Pharmacol. 2005;61(12):873-80 Jauch, et al. Guidelines for the early management of patients with acute ischemic stroke. 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