s TPA and Appropriate documentation for contraindications: A conversation with The Joint Commission and a Physician Perspective Shyam Prabhakaran, MD, MS Rush University Medical Center 11/7/08

s Source: JAMA, 2000;283: Recommendations for the Establishment of Primary Stroke Centers Acute Stroke Care Rapid, accurate assessment Imaging protocols Guideline based order sets, protocols, and pathways Quality and outcome monitoring

s DSC/Stroke-4: Tissue Plasminogen Activator (t-PA) Considered Measure: All patients who present at a hospital with symptoms of an ischemic stroke with symptom onset of 3 hours or less should be considered to receive intravenous (IV) t-PA Rationale: The administration of thrombolytic agents to carefully screened, eligible patients with acute ischemic stroke has been shown to be beneficial in some recent clinical trials. IV t-PA is the only FDA approved treatment for acute ischemic stroke.

s Acute Stroke Evaluation: 60 Minute or Less Protocol Triage – 10 minutes: Patient compliant, focused history, vital signs, GCS, ECG ED Physician – 10 to 20 minutes: Focused history and physical exam, laboratories, CT Scan-codes stroke (Goal: 25 minute door-to-CT) –Vital sign monitoring, neurologic checks, seizure and aspiration precautions Neurology Consult – minutes: Review history, physical exam, review CT Scan Treatment Decisions

s Door to IV TPA Goal < 60 Minutes = Time is Brain STARS Registry –38 community, 18 academic hospitals, 389 IV TPA pts –Median door to needle time: 96 minutes CDC 4 State Pilot Acute Stroke Registry –98 hospitals, 6867 acute patients, 118 IV TPA –Treatment within target 60 minutes: 14.4% Stroke Onset to IV TPA < 3 hours

s Differential Diagnosis Ischemic Stroke Hemorrhagic Stroke Trauma Meningitis/Encephalitis Mass –tumor –subdural hematoma Seizure: post-ictal Metabolic –hyperglycemia –hypoglycemia –post-cardiac arrest –drug overdose

s CT Results

s Strategies in Acute Ischemic Stroke Proven –Supportive Care: –Treat hypoxia –Maintain normothermia –Avoid hyperglycemia –Early parental fluids and permissive hypertension –Recanalization (Thrombolytics < 3 hours) –Prevent Clot Propagation –Early Implementation of Secondary Prevention

s NIH/NINDS tPA study Design Randomized, double-blind placebo-controlled trial Raters different from baseline examiners Two parts Part 1: 24-hour improvement Complete resolution of deficit or improvement of 4 points on the NIH stroke scale Part 2:3-month outcome Consistent and persuasive difference in proportion of patients with minimal or no deficit

s Eligibility Criteria Ischemic stroke with clearly defined time of onset < 3 hours Baseline CT negative for hemorrhage Age > 18 years Moderate to severe symptoms

s Treatment Dose0.9 mg/kg (maximum 90 mg) 10% given as IV bolus 90% constant IV infusion over over 1 hr Other meds No other anticoagulants or antiplatelet agents for 24 hours post tPA Strict BP control (< 180/105 mmHg) post-tPA

s >18 y.o. with ischemic stroke < 3 hours Moderate or severe symptoms Coagulation status –If patient has received recent anticoagulation therapy: PT < 15 sec. and normal PTT –Platelets > 100,000 Blood Pressure SBP<185mmHg, DBP <110 Glucose > 50 mg/dl Thrombolytic Therapy Checklist Adams HP, et al. ASA Stroke Council. Stroke. 2003;34:

s Other exclusion criteria Prior stroke or head trauma within 3 months Major surgery within 14 days History of ICH or SAH GI or GU hemorrhage within 21 days Arterial puncture at non- compressible site within 7 days Lumbar puncture within 7 days Rapidly improving or mild symptoms Seizure at stroke onset SBP > 185 or DBP > 110 Glucose 400 mg/dL Any oral anticoagulants Elevated PT > 15s or PTT > 1.5x normal Platelet count < 100,000

s NINDS TPA Stroke Trial Global outcome statistic: OR=1.7, 50% v. 38%= 12% benefit Excellent outcome at 3 months on all scales 52% 38% 43% 26% 45% 31% 34% 21% 0% 10% 20% 30% 40% 50% 60% Barthel Index Rankin Scale Glasgow Outcome NIHSS score TPA Placebo

s Benefit at 3 months –55% more likely to be neurologically normal 12% absolute benefit NNT is 8 –60-70% more likely to have favorable outcome Risk of sICH is 6.4% –Overall benefits include ICHs Adams HP Jr. Stroke 2003;34:

s Number Needed to Treat to Benefit from IV TPA Across Full Range of Functional Outcomes OutcomeNNT Normal/Near Normal 8.3 Improved 3.1 For every 100 patients treated with tPA, 32 benefit, 3 harmed Stroke 2007; 38:

s Marler JR et al. Neurology 2000;55:

s Efficacy similar to NINDS trial Rate of ICH: 4%-6% Risk of ICH increases with protocol violations –Time >3 hours –Poor blood pressure control –Using prohibited agents –Wrong dose 0.9 mg/kg Maximum dose: 90 mg –Elevated blood sugar also increases risk Adams HP, et al. ASA Stroke Council. Stroke. 2003;34: Use of tPA in Routine Clinical Practice

s Only % of stroke patients review IV tPA Reasons for exclusions –Delayed patient arrival (>3 hrs) –In-hospital delays in completion of required tests prior to rt-PA administration –Presence of exclusion criteria –Physician reluctance to administer the drug due to inexperience, unavailability of neurological consultation, or fear of medical complications or legal ramifications

s #1 Reason for IV TPA exclusion: Delay to ER 73% Only 27% of those presenting within 3 hours were treated with IV TPA Of those presenting <3 hours (n=314): 1. Rapid improvement18% 2. Mild symptoms13% 3. Protocol exclusion14% 4. Delay in ER9% 5. Comorbidity8% Barber PA, et al. Neurology 2001;56:

s Recommendations for appropriate use of tissue plasminogen activator Key elements –Acute stroke teams –Written care protocols –Integrated emergency response system and infrastructure for hyperacute evaluation –Documentation checklist –Quality improvement programs JAMA, June 21, 2000-Vol 283, No. 23

s Acute Stroke Team Dedicated pager: “Stroke Code” Arrival at bedside within 15 minutes Protocols/standing orders in place for all stroke patients: –Written stroke protocols for IV tPA associated with fewer complications –Post treatment care pathways (BP control after tPA) Stroke team members –Stroke neurologist –Emergency room physician –Residents (if applicable) –Nurses –Radiologist and technicians –Pharmacist

s Hospital Logistics Neuroradiology –CT available 24 hours a day –Completed within 25 minutes –Read within 45 minutes Laboratory services –Results of CBC, BMP, coags back within 45 minutes Family, patient, staff, and EMS education Data collection and performance improvement Community outreach and education Institutional support and leadership

s Acute Stroke Pager

s RUMC ALGORITHM ACUTE STROKE (ED) Clinical Suspicion of ACUTE STROKE < 12 Hours from onset a) New neurological deficit (weakness, numbness, change in vision, change in speech, clumsiness, trouble walking) OR b) Acute decrease in level of consciousness OR c) Worst headache of life Emergency Department Activate Acute Stroke Pager ( ) Notify ED attending Vital signs and finger stick Place 2 large bore peripheral IV’s, NPO Labs (with special label): - CBC, PT/PTT, - Chem7, troponin - Type & hold Urine HCG (pre-menopausal women) Notify Radiology technician (26874) STAT Head CT (done w/i 25 min) Neurologic exam/determine onset time Obtain 12-lead ECG, pulse ox Give supplemental O2 for Sp02<93% Obtain chest X-Ray STAT Alert pharmacy if tPA eligible Acute Stroke Team At bedside within 15 minutes of page. Confirm time of onset (last known normal) Obtain Past Med Hx - Prior ICH or SAH - Known cerebral AVM, aneurysm, tumor - Recent trauma or surgery - Review current medications Check vital signs (review BP) Perform NIHSS Review Head CT (read by 45 minutes of arrival) Review available lab tests (gluc, plts, coags) Discuss with Stroke Attending INITIATE TREATMENT

s Stroke Labs

s Jan FebMar Apr May Jun Jul Stroke lab protocol change 3/17/07 CT protocol change 2/1/07

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s Evaluate Assessment Review Summary Reports Implement Refined Protocol Coordinate Implementation of Refined Protocol Assess Stroke Treatment Rates Analyze Process from ED to Discharge, Rates of TPA Use, Other Standards of Care Refine Protocol Identify Areas for Improvement

s Goal door-to-treatment time < 60 minutes and reduce treatment-related complications Continue to review outcomes following acute stroke interventions –Monthly meetings –Continue to improve CT and lab times –Chart review for protocol violations and documentation errors Re-educate staff members on protocols – s –Staff meeting presentations –In-services –Stroke champion