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Guidelines in the acute management of Ischemia stroke 0-3 hrs. INTRODUCTION Incidence of ABA : 2.4 per 1000 people per year 0.2 % per year between 55-64 yrs of age 2 % per year for persons >85 yrs. 1 per 1000 persons per year 10,00,000 strokes per year in India 3000 strokes a day In Chennai alone, 1000 cases a month 2% of all admissions Crude prevalence rate is 220/100000. Impact of ABA and economic burden Someone suffers a Brain Attack every 33 secs. Every 3.3 mins., someone dies of a stroke Atleast 50,00,000 Indians are Stroke survivors Stroke costs in India: Rs. 3000 – 4000 Crores a year Rationale behind developing ABA team 1. Targets the unique needs of the Stroke victim 2. A radical change has taken place in the way stroke is managed. A ‘wait and hope’ approach has been replaced by a ‘rapid diagnosis and intervention’ approach. 3. A protocol driven, appropriately equipped Stroke program run by a well-trained staff is an absolute necessity to implement the newer stroke treatments. 4. Acute Stroke units decrease length of hospital stay. Rationale behind developing ABA team Time is Brain! ABA teams provide the most efficient and effective care during acute Hospitalization, deliver thrombolytic therapy and improve outcome. 0 10 90 20 30 40 50 minutes 60 70 80 Estimated thresholds Core Penumbra 0 20 10 Infarct Volume 0 30 60 120 180 240 360 480 min 720 1080 1440 Time Oligemia Normal range 40 60 Hyperperfusion CBF ( ml/100g/min) Ischaemic core and penumbra Relationship of Ischemia over Time One Hour from Onset penumbra core 3 Hours from Onset 6 Hours from Onset Heterogeneous Disease: Infarction at different rates 1 Hr average slow fast 3 Hr 6 Hr Acute Brain Attack Team Objectives: 1. To form a multi-disciplinary Stroke team. 2. To implement new advances that improve stroke outcome. 3. To train Medical, Neurological and Neurosurgical residents. 4. To participate in International Clinical Research and Stroke trials. Acute Brain Attack Team Requirements: 1. 6 beds in Neuro Critical Care and 6 beds in Stroke Unit 2. E R Physicians interested in Stroke 3. 24 Hr/365 days ‘Full time’ Stroke/ Vascular Neurologists 4. Nursing staff trained in stroke care 5. Stroke Rehab Programme 6. Physiotherapists 7. Speech Therapists 8. Dietitians Anticoagulants and Antiplatelet Agents in Acute Ischemic Stroke Report of the Joint Stroke Guideline Development Committee of: American Academy of Neurology and the American Stroke Association (a Division of the American Heart Association) B.M. Coull, MD; L.S. Williams, MD; L.B. Goldstein, MD; J.F. Meschia, MD; D. Heitzman, M.S. Chaturvedi, MD; K.C. Johnston, MD; S. Starkman, MD; L.B. Morgenstem, MD; J.L. Wilterdink,MD; S.R. Levine, MD &; J.L. Saver, MD. Recommendations A tale of two drugs 1. Patients with acute ischemic stroke presenting within 48 hours of symptom onset should be given aspirin (160 to 325 mg/day) to reduce stroke mortality and decrease morbidity, provided contraindications such as allergy and GI bleeding are absent, and the patient has or will not be treated with recombinant tissue-type Plasminogen Activator (Grade A). The data are insufficient at this time to recommend the use of any other platelet antiaggregant in the setting of acute ischemic stroke. Recommendations (Contd.) 2. Subcutaneous unfractionated heparin, LMW heparins, and heparinoids may be considered for DVT prophylaxis in at-risk patients with acute ischemic stroke, recognizing that nonpharmacologic treatments for DVT prevention also exist (Grade A). A benefit in reducing the incidence of PE has not been demonstrated. The relative benefits of these agents must be weighed against the risk of systemic and intracerebral hemorrhage. Recommendations (Contd.) 3. Although there is some evidence that fixed-dose, subcutaneous, unfractionated heparin reduces early recurrent ischemic stroke, this benefit js negated by a concomitant increase in the occurrence of hemorrhage. Therefore, use of cutaneous unfractionated heparin is not recommended for decreasing the risk of death or related morbidity or for preventing early Stroke recurrence (Grade A). Suspected Acute Ischemic Stroke/TIA DAY 1---1st 24hrs Emergency Department Protocols Acute Stroke Nursing Protocol t-PA reconstitution and Neurologist Protocols IV thrombolysis administration instructions IA thrombolysis Acute Stroke Blood Draw and ED Order Sheet Acute stroke Patient Clinical Examination Form Stroke scales Post-thrombolysis Management NINDS - Stroke evaluation targets for potential Thrombolytic candidates Door to MD evaluation 10 min Door to CT completion 25 min Door to CT read 45 min Door to treatment 60 min Access to neurological expertise 15 min Access to neurosurgical expertise 2 hrs Admit to monitored bed 3 hrs Acute Brain Attack Team OVERVIEW OF PROTOCOL: 1.Creation of Public awareness about ABA 2.Time 0 : Apollo Ambulance called for 3.Pre – arrival 4.First hour after patient arrives in EMR 5.Second Hour 6. First 2 days 7.Follow up. Acute Brain Attack Team Education / Creation of awareness among the Public that: 1. Stroke is called Acute Brain Attack and is a medical emergency. 2. Effective treatment is available if rushed to Apollo Hospitals within the first 3-6 hours, after an ABA. CREATION OF AWARENESS AMONG THE PEOPLE Stroke is “ACUTE BRAIN ATTACK" Exposure in TV channels as a video skit, Stroke information. Slide projection in Cinema theatres & other gatherings. AIR (All India Radio) skits, small talks & announcements. Handouts in English,Tamil,Telugu & Hindi in gatherings. Posters in prominent places, road junctions & public places. Lectures - periodic at public places / functions / health meetings. Education / Creation of awareness among the Public Recognize the warning signs of Stroke like: 1.Sudden numbness or weakness of the face, arm or leg on one side of the body. 2.Sudden confusion, trouble speaking or understanding. 3.Sudden trouble seeing in one or both eyes. 4.Sudden trouble walking, dizziness, loss of balance or Coordination. 5.Sudden severe headache or coma. The Chennai Acute Brain Attack Consortium Formed on October 29, 2009, World Stroke Day. Prof. M.R.SIVAKUMAR, MD, DM, FRCP, FAAN, FAHA, is the Program Director and Co-ordinator ALL 95000 17893 IF ANY OF THE ABOVE SYMPTOMS ARE NOTED(24x7). Time Zero - Ambulance is called The ambulance operator will be asked to rush the ambulance to the Stroke victim’s house. The Stroke patient will be transported to the nearest scan center where facilities for CT/MRI Scans are available. After the Neuroimaging, the patient will be admitted to the nearest Hospital equipped with Stroke Unit and Acute Stroke Protocols. Pre -arrival: Before patient arrives at the ER The ambulance operator should: 1.Dispatch the ambulance immediately. 2.Inform the Emergency Room/ Neurologist that a Stroke victim is on the way. EMR Medical Officer should: 1. Alert the Radiology Staff in the CT scan area/Duty Radiologist. 2. Inform Stroke Neurologist Pre-arrival Phone contact eye-witnesses or family members to obtain: - details of the event (time of onset) - relevant medical history, medications, allergies - open discussion about risk/benefit of potential emergency therapies - ensure open line of communication with next of kin Acute Stroke Nursing Protocol T-PA reconstitution and administration instructions Acute Stroke Blood Draw Order Sheet Acute Stroke Patient Clinical Examination Form Acute Stroke Action Plan Acute Stroke Nursing Protocol Acute Stroke Nursing Protocol Record time of onset of symptoms Note patient’s PCP and primary neurologist Notify ED attending Notify Stroke Neurologist Obtain vital signs Ask the family medical history from patient or family: Acute Stroke Nursing Protocol Recent trauma, dates Recent surgery, dates Recent procedure, dates Prior stroke/TIA, dates HTN; DM; CAD; AF Bleeding disorder; coumadin use Aspirin use ; GI, GU, or pulmonary hemorrhage Migraine; Metal fragments, or pacemaker First Hour - after the patient arrives in the ER: The ER Medical Officer should note the time of arrival of the patient and: 1.Inform CT scan room, Stroke Neurologist immediately. 2.ABC - Resuscitation if needed. 3.Quick History/Examination to confirm the initial suspicion of ABA. 4.Phlebotomy -->Send blood for Complete Blood Count, glucose, Creatinine, Urea, Electrolytes, PT, PTT. Leave IV plug in. 5.Check bedside glucose with a drop of blood from the phlebotomy. Treat Hypoglycemia (<70mg/dl) immediately. First Hour - after the patient arrives in the ER: 6.Optimum MAP is 130 mm of Hg. If BP is low, start IV Normal Saline and if BP is high ( > 180/110 mm/Hg.), place a Nitrodisc (40 mg). 7.ECG - If ischemic changes are noted, request Cardiac Enzymes in addition to other tests.Treat arrhythmias if noted. 8.Check vital signs every 10 minutes. 9.Wheel patient to CT scan area. 10. Perform Transcranial Doppler at bedside, Carotid/Vertebral /TC Doppler and ECHO Cardiogram in Vascular lab. Start collecting the result of investigations. Transcranial Doppler in AIS Can help identify intracranial vascular disease Useful to guide and monitor acute therapy Useful for monitoring for emboli, and based on location of MES (microembolic signals, nHITS), can differentiate between cardioembolic, large artery, medium vessel sources for stroke TCD performed 6 hours after stroke onset, if normal was predictive of early improvement, and if abnormal was predictive of early deterioration. TCD in Acute Stroke MES have been detected distal to intracranial arterial occlusions, and when found in high numbers appear to herald the break-up of the thrombus. Some experimental evidence suggests that ultrasound (although at frequencies lower than those used for TCD imaging) may enhance thrombolysis of intra-arterial thrombi. Microembolic Signals (HITS) High intensity Transient Unidirectional Occur randomly in cardiac cycle Characteristic chirping sound MES have particular characteristics that distinguish them from the waveform, background, and artifacts that move across the monitoring screen. Sonothrombolysis(TCD monitoring with i.v. tPA) TCD and Neuroimaging Data Pre-Sonothrombolysis 49 yo presented with Rt. Sided Hemiplegia/ Dysphasia since 90 min. Post-Sonothrombolysis Acute Brain Attack Team The radiology technician should make him/herself available immediately. Should perform a non-contrast CT scan of the Brain as the ‘next case’ and the films should be printed out as soon as possible. The stroke Neurologist should make him/herself available with the first call and arrive in the ER as soon as the patient gets there. NCCT pre and post t-PA CT Angiogram Acute Brain Attack Team First Hour: The Stroke Neurologist would evaluate the clinical picture of the patient, review the CT Head and the results of the investigations. If the patient turns out to have an intracerebral or subarachnoid bleed, follow appropriate protocol. If the patient has an infarct, a decision needs to be made if rTPA could be safely used in the patient. The pharmacy needs to be alerted immediately once a decision is made to use r-TPA Acute Brain Attack Team Intravenous r-TPA would be administered in the ER, only after getting an informed consent and under the direct supervision of the Neurologist. The patient should be on ECG monitor and vital signs should be checked every 10 minutes during the r-TPA infusion. The patient would be moved to the Acute Stroke Unit. Second Hour: The Stroke Neurologist would evaluate the clinical picture of the patient, review the CT Head and the results of the investigations. If the patient turns out to have an intracerebral or subarachnoid bleed, follow appropriate protocol. If the patient has an infarct, a decision needs to be made if r-TPA could be safely used in the patient. The pharmacy needs to be alerted immediately once a decision is made to use r-TPA TPA Intravenous r-TPA would be administered in the ER, only after getting an informed consent and under the direct supervision of the Neurologist. The patient should be on ECG monitor and vital signs should be checked every 10 minutes during the r-TPA infusion. The patient would be moved to the Acute Stroke Unit. Exclusion Criteria for Thrombolytic Therapy: Absolute: 1. CT or MRI evidence of hemorrhage 2. Complete resolution of symptoms Relative: 1. CT changes > one-third of MCA territory 2. Hypertension (systolic > 185, diastolic > 110) that remains unresponsive to antihyperstensive management . 3. History of GU or GI bleeding within three (3) weeks 4. History of CPR, extensive trauma, or surgery within 2 weeks 5. History of stroke within two (2) weeks 6. PT > 15, platelets < 100,000, INR > 1.7 7. LP or non-compressible arterial puncture within one week 8. History of seizure at time of onset Clinical Cautions 1. Clinical presentation suggestive of SAH, even if CT is negative 2. Age > 80 3. Active pericarditis or pericardial infusion 4. Glucose < 50 or > 400 5. NIH Stroke Scale > 22 6. Rapidly improving symptoms IV rt-PA reconstitution & Dosing Dose: 0.9 mg/Kg ( Maximum: 90 mg.) 10% bolus, rest as an infusion over 1 hour. Intravenous/Intra-Arterial Therapy: Consider for the following patients: Patients with suspected large vessel occlusive disease(carotid terminus, basilar artery, M1, proximal M2) Patients with a diffusion-perfusion mismatch on MR Patients being transferred from other institutions Consent for IV/IA therapy should be obtained at the institution initiating IV therapy. TIBI (Thrombolysis in Brain Ischemia) Grade 0: Absent - absent flow signals are defined by the lack of regular pulsatile flow signals despite varying degrees of background noise. Grade 1: Minimal - systolic spikes of variable velocity and duration; absent diastolic flow during all cardiac cycles based on a visual interpretation of periods of no flow during end diastole(reverberating flow is a type of minimal flow). Grade 2: Blunted - flattened systolic flow acceleration of variable duration compared to control; positive end diastolic velocity and PI < 1.2. TIBI (Thrombolysis in Brain Ischemia) Grade 3: Dampened - normal systolic flow acceleration; positive end-diastolic velocity; decreased MFVs by >30% compared to control. Grade 4: Stenotic - MFV >80 cm/s and velocity difference >30% compared to control or; if both affected and comparison sides have MFV <80 cm/s due to low end-diastolic velocities, MFV >30% compared to the control side and signs of turbulence. Grade 5: Normal - <30% MFV difference compared to control; similar waveform shapes compared to controls. Carotid Doppler Flow Velocity Criteria Peak Systolic Velocity (cm/sec) < 140 > 140 >> 140 Variable Velocities No detectable flow Diastolic Velocity (cm/sec) < 40 < 110 > 110 Variable N/A ICA/CCA % Diameter Ratio Stenosis <2 < 50% >2 50-75% >3 75-95% Variable 95-99% (Subtotal occlusion) N/A Probable occlusion Onset 3-6 hours: Intra-Arterial Thrombolysis ACT: Baseline, 1 hour, 2 hours 1. Administer 2000 units heparin IV bolus if thrombus is identified angiographically. 2. Start maintenance infusion of heparin at 450 units/hour. 3. Position 2.3 French microcatheter just distal to occlusion. 4. Infuse 2 mg TPA (2 mg/2 cc NS) over 4 minutes distal to thrombus. 5. Retract catheter into thrombus. Onset 3-6 hours: Intra-Arterial Thrombolysis 6. Infuse 2 mg TPA (2 mg/2 cc normal saline) over 4 minutes into thrombus. 7. Start maintenance infusion of 10 mg/hr TPA using infusion pump. 8. Perform control angiogram every 15 minutes (or as needed) after start of maintenance TPA infusion (option to mechanically disrupt every 15 min.). 9. Perform neurological examination every 15 minutes to assess level of consciousness and upper extremity motor function 10. Infuse maintenance dose for a maximum of 2 hours to a maximum time after onset of 8 hours. 11. Consider more aggressive mechanical disruption (i.e., snare) if clot has not resolved after 1 hour. 12. Terminate infusion prior to 2 hours if complete clot lysis is achieved. 13. Total IA TPA dose = 24 mg. tPA Dosing chart Weight (Lbs)Conv. to Kg) Total Dose t-PA Bolus t-PA Bolus Discard Dose Infusion dose Inf.rate Kg ( mg) (mg) (ml) ( mg) (mg) (ml/hr) 220+ 100.0 90.0 9.0 9.0 10.0 81.0 81.0 210 95.5 85.9 8.6 8.6 14.1 77.3 77.3 200 90.9 81.8 8.2 8.2 18.2 73.6 73.6 190 86.4 77.7 7.8 7.8 22.3 70.0 70.0 180 81.8 73.6 7.4 7.4 26.4 66.3 66.3 170 77.3 69.5 7.0 7.0 30.5 62.6 62.6 160 72.7 65.5 6.5 6.5 34.5 58.9 58.9 150 68.2 61.4 6.1 6.1 38.6 55.2 55.2 140 63.6 57.3 5.7 5.7 42.7 51.5 51.5 130 59.1 53.2 5.3 5.3 46.8 47.9 47.9 120 54.5 49.1 4.9 4.9 50.9 44.2 44.2 110 50.0 45.0 4.5 4.5 55.0 40.5 40.5 100 45.5 40.9 4.1 4.1 59.1 36.8 36.8 Procedure consent form ----------Hospitals, Chennai. Patient’s name : Unit No. : Procedure: I have explained to the patient / family / guardian the nature of the patient’s condition, the nature of the procedure, the benefits to be reasonably expected compared with alternative approaches. I have discussed the likelihood of major risks or complications of this procedure including (if applicable) but not limited to loss of limb function, brain damage, paralysis, hemorrhage, infection, complications from transfusion of blood components, drug reactions, blood clots, and loss of life. I have also indicated that with any procedure there is always the possibility of an unexpected complication. Dr. has explained to me (or my family member) why they believe a stroke is happening and which of the available methods would be most likely to improve my condition. They have explained the risks and benefits of the drugs and techniques available to dissolve blood clots in the brain and possible alternative treatments. They have recommended use of the INTRAVENOUS DRUG, recombinant Tissue Plasminogen Activator (clot – dissolver) to dissolve the blood clot. INTRAVENOUS THROMBOLYSIS: Procedure consent ( contd.) The risks include: 1. Death, Stroke or permanent neurologic injury (paralysis, coma,etc) 2. Worsening of stroke symptoms from swelling or bleeding in the brain 3. Bleeding in other parts of the body 4. Need for blood transfusions to replace blood or clotting factors 5. Other unexpected complications. All questions were answered and the patient / family / guardian consents to the procedure. (Physician’s Signature) Date : Dr. has explained the above to me and I consent to the procedure. I understand that APOLLO HOSPITALS is an academic medical center and that residents, registrars, fellows and students in medical and allied disciplines may participate in this procedure. In addition, I understand that tissue, blood or other specimens removed for necessary diagnostic or therapeutic reasons may subsequently be used by the Hospital or members of its professional staff for research or educational purposes. ( patient’s / family’s / guardian’s signature) Symptomatic hemorrhage after t-PA STAT head CT, if ICH suspected Consult Neurosurgery for ICH Check CBC, PT, PTT, platelets, fibrinogen and D-dimer. Repeat q 2 h until bleeding is controlled Give FFP 2 units every 6 hours for 24 hours after dose Give cryoprecipitate 20 units. If fibrinogen level < 200 mg/dL at 1 hr, repeat cryoprecipitate dose. Give platelets 4 units Give protamine sulfate 1 mg/100 U heparin received in last 3 hours (give inital 10 mg test dose. Maximum dose :50 mg) Institute frequent neurochecks and therapy of acutely elevated ICP, as needed May give aminocaproic acid (Amicar) 5 g in 250 cc NS IV over 1 hr as a last resort. NIH Stroke Scale The NINDS t-PA Stroke Trial No. ___ Pt. Date of Birth ___ ___/___ ___/___ ___ Date of Exam ___ ___/___ ___/___ ___ Intervals : 1[ ] Baseline 2[ ] 2 hours post treatment 3[ ] 24 hours post onset of symptoms ±20 mins. 4[ ] 7-10 days 5[ ] 3 months 6[ ] Other Total Score : 42 1a. Level of Consciousness 1b. LOC Questions 1c. LOC Commands 2. Best Gaze 3. Best Visual 4. Facial Palsy 5. Best Arm Movement 6. Other Arm 7. Best Motor Leg 8. Other Leg 9. Limb Ataxia 10. Sensory 11. Neglect 12. Dysarthria 13. Best Language 14. Change from Previous Exam Alert Drowsy Stuporous Coma Answers both correctly Answers one correctly Incorrect Obeys both correctly Obeys one correctly Incorrect Normal Partial gaze palsy Forced deviation No visual loss Partial hemianopia Complete hemianopia Bilateral hemianopia Normal Minor Partial Complete No drift Drift Can’t resist gravity No effort against gravity No movement For brainstem stroke use same scale as No drift above Drift Can’t resist gravity No effort against gravity No movement For brainstem stroke use same scale as Absent above Present in upper or lower Present in both Normal Partial loss Dense loss No neglect Partial neglect Complete neglect Normal articulation Mild to moderate dysarthria Near unintelligible or worse No aphasia Mild to moderate aphasiaaphasia Severe Mute Same Better Worse 0 1 2 3 0 1 2 0 1 2 0 1 2 0 1 2 3 0 1 2 3 0 1 2 3 4 0-4 0 1 2 3 4 0-4 0 1 2 0 1 2 0 1 2 0 1 2 0 1 2 3 S B W Baseli ne 30 Min. 1 hr 2 hr 24 hr 48 hr 7-10 days Modified Rankin Scale Patient Name: RANKIN Rater Name: SCALE (MRS) Date: __ Score Description 0 No symptoms at all 1 No significant disability despite symptoms; able to carry out all usual duties and activities 2 Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3 Moderate disability; requiring some help, but able to walk without assistance 4 Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6 Dead TOTAL (0–6): _______ References Rankin J. “Cerebral vascular accidents in patients over the age of 60.” Scott Med J 1957;2:200-15 Bonita R, Beaglehole R. “Modification of Rankin Scale: Recovery of motor function after stroke.” Stroke 1988 Dec;19(12):1497-1500 Barthel Index First day: Transcranial doppler repeated after 6 hours if abnormal earlier. Repeat CT Scan if I.V. r-TPA has been used. Continuous ECG monitor. Hourly vital signs and neurological status examination. Swallowing/nutrition status assessed and treated appropriately. DVT prophylaxis instituted. Physiotherapy/ Speech therapy started, if condition is stable. Acute Brain Attack Team Second day: Continue medical management and monitoring. Ensure that detailed case evaluation notes, NIHSS, mRS and Barthel Index are documented. Standard treatment with Alteplase to Reverse Stroke ( STARS) study No. Mean age(yrs.) Time to treatment(%) 0-90 mins. 91-180 mins. 180 - 270 mins. Median time from stroke onset to tPA Rx. Median time from ER arrival to tPA Rx. STARS 389 69 CVRF 174 60.3(23-78) 4.2 82.3 13.5 21.40 75.00 3.60 2 h 44 m 2h,22m 1 h 36m 1h28m Standard treatment with Alteplase to Reverse Stroke ( STARS) study Baseline NIHSS Score Mean Symptomatic ICH(%) Asymptomaic ICH(%) Outcome at 30 days(%) MRSS 0-1 MRSS 0-2 Mortality rate STARS CVRF 14 3.3 8.2 12 10.71 7.14 35 43 13 53.57 39.28 2.34 STROKE package Costs about Rs. 8 – 17000/- for investigations. The cost of 50 mg of r-TPA is around Rs.44,000/-( 0.9 mg/Kg. Body wt.). The cost for stay in the Hospital for 1 week will depend on the type of room and will be around Rs. 5,000 to Rs.20,000.