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Stroke Reperfusion Therapy: IV t-PA Treatment Phase

IV tPA Administration for Adult Patients Arriving Within 3 Hours.

Comments in brackets denote activities specific to MGH, or additional commentary regarding national standards or guidelines. For example:

Prior to making any medical decisions, please view our disclaimer.

Consent Form

Indications for IV tPA

  • Age greater than or equal to 18 yrs
  • A significant neurologic deficit expected to result in long term disability
  • Non-contrast CT scan showing no hemorrhage or well-established new infarct
  • Acute ischemic stroke symptoms with onset or last known well, clearly defined, less than 3 hours before t-PA will be given (note additional warnings for the 3-4.5 hour time period below)

Contraindications

These are based on FDA approved labeling of alteplase.

Contraindications include any of the following:

  • SBP greater than 185 or DBP greater than 110 mmHg (see BP Management)
    [despite medical intervention to lower it]
  • Recent intracranial or spinal surgery, head trauma, or stroke (less than 3 months)
  • History of intracranial hemorrhage or brain aneurysm or vascular malformation or brain tumor
    [may consider iv tPA in patients with CNS lesions that have a very low likelihood of bleeding such as small unruptured aneurysms or benign tumors with low vascularity]
  • Active internal bleeding (within prior 21 days)
  • Platelets less than 100,000, PTT greater than 40 sec after heparin use, or PT greater than 15 or INR greater than 1.7, or known bleeding diathesis
    [see protocol for starting tPA while awaiting results of PT/PTT]
  • Current use of novel oral anticoagulants [NOACs] (direct thrombin inhibitors or factor Xa inhibitors) within 48 hours of evaluation or with abnormal labs if >48hrs (aPTT, INR, platelet count, or ECT, TT, or factor Xa essays)
  • Suspicion of subarachnoid hemorrhage
    [by imaging or clinical presentation]
  • Arterial puncture at non-compressible site within prior 7 days
  • CT findings (ICH, SAH, or major acute infarct signs)
    [e.g. hypodensity greater than 1/3 cerebral hemisphere]

Warnings

These conditions may increase the risk of unfavorable outcomes but are not necessarily a contraindication to treatment:

  • Seizure at onset
    [if residual deficits are thought to be due to the postictal state rather than to ischemia]
  • Major surgery/trauma (less than 15 days)
  • Recent GI or urinary tract bleeding (within 21 days)
  • Stroke severity - too severe (e.g., NIHSS greater than 22)
    [At MGH, we typically do not exclude patients based on an increased NIHSS alone.]
  • Glucose less than 50 or greater than 400 mg/dl
    [if residual deficits are due to the altered metabolic state rather than to ischemia. If rapid diagnosis of vascular occlusion can be made, treatment may be given.]
  • Recent MI (within 3 months) and/or Left heart thrombus documented
  • Increased risk of bleeding due to any of the following:
    • Acute pericarditis
    • Subacute bacterial endocarditis (SBE)
    • Hemostatic defects including those secondary to severe hepatic or renal disease
    • Pregnancy
    • Diabetic hemorrhagic retinopathy, or other hemorrhagic ophthalmic conditions
    • Septic thrombophlebitis or occluded AV cannula at seriously infected site
    • Patients currently receiving oral anticoagulants, e.g., Warfarin sodium
      [and INR greater than 1.7]
    • Advanced age
  • Rapid improvement
  • Stroke severity too mild
    [e.g. anticipate ability to discharge to home]
  • Life expectancy less than 1 year or severe co-morbid illness or CMO on admission

*For extended window IV thrombolysis (3.0-4.5 hours from last seen well), additional relative exclusion criteria exist: http://www2.massgeneral.org/stopstroke/PostIVtPA345window.aspx

t-PA Dosing

Calculate the exact dose of t-PA using the t-PA Dosing Calculator if patient's weight is known or measured. If estimating weight to 10 lb intervals, the Dosing Sheet below may be used.

Estimated Weight (lbs) Conversion to Kilograms (Kg) Total iv t-PA Dose (mg) at 0.9 mg/kg t-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+ 100.0 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

Treatment Phase

ED Nurse Responsibilities:

  • Mix and draw up tPA per protocol:
    • Provide physician with the 10% bolus dose, either in CT area or ED bay
    • Prepare the infusion
    • If tPA is mixed but patient does not receive drug, notify pharmacist to return mixed t-PA and initiate rebate
  • Once infusion begins monitor vital signs as follows:
    • Every 15 min for 2 hours, then:
    • Every 30 minutes for 6 hours, then:
    • Every 60 minutes for 16 hours
  • Notify physician immediately if SBP/DBP greater than 175/100
  • Do not insert Foley catheter or nasogastric tube unless ordered
  • Document hourly neurologic reassessment (more frequently if patient's condition changes)

ED Physician Responsibilities:

  • Stand-by for emergent management of potential known side effects of IV t-PA:
    • Bleeding complications
    • Angioedema

Neurologist Responsibilities (includes Resident, Fellow or Attending):

  • Calculate IV tPA dose based on weight estimate and tPA dosing table:
    • Document estimated weight
    • Review with nursing staff to ensure accuracy
    • Confirm BP within safe limits
    • Write order for tPA total dose as a bolus plus infusion
    • Administer the 10% bolus over 1 minute and document time on ED medication order sheet
  • Repeat NIHSS evaluation if patient exam has changed significantly
  • Facilitate IAT for patients that are eligible
  • Strict control of blood pressure for 24 hours per protocol
  • Request an Acute Stroke admission bed to the CMF/ICU Service. The patient remains under the care of the Acute Stroke Team until officially transferred to the CMF/ICU Attending.
  • Patients eligible for the Acute Stroke Care Unit (ASCU) admission on Lunder 7 post-IV t-PA must be strictly considered following the ACSU protocol .
  • Coordinate the post tPA care with the ED attending to ensure continuity until the patient can be transferred out of the ED
  • Management of blood pressure (see BP Management)

Post Treatment Phase

ED Nurse Responsibilities

  • Document neurologic assessment hourly or more frequently if changes occur
  • Vital sign monitoring as described above under Treatment Phase
  • Verify the patency of IV and completion of the tPA dose
  • Provide nursing report to the accepting nurse
  • Provide family/patient with appropriate resource materials about stroke

Neurologist Responsibilities (includes Resident, Fellow or Attending)

  • ICU/Acute Stroke Care Unit admission for monitoring during first 24 hours
  • Use the standard post- t-PA order set and modify, as indicated
  • Order routine non-contrast head CT at 24 hours post treatment (or STAT with any worsening in neurological status)
  • Vital signs every 15 minutes for 2 hours, then every 30 minutes for 6 hours, then every 1 hour for 16 hours
  • Strict control of blood pressure for 24 hours per protocol
  • Restrict patient intake to strict NPO including meds until swallowing screen performed and passed
  • Continuous pulse oximetry monitoring, order oxygen by nasal cannula or mask to maintain O2 sat greater than 95%
  • Tylenol 650 mg po(pr if still NPO) every 4 hours PRN T greater than 99.4; consider cooling for T greater than 102
  • No antiplatelet agents or anticoagulants (including heparins for DVT prophylaxis) in first 24 hours
  • No Foley catheter, nasogastric tube, arterial catheter or central venous catheter for 24 hr, unless absolutely necessary
  • For any acute worsening of neurologic condition:
    • For suspected symptomatic hemorrhage after t-PA or other plasminogen activator has been given:
      • Hold administration of IV t-PA if still infusing until head CT or alternative imaging (if hemorrhage is suspected elsewhere) has been completed and shows no evidence of bleeding.
      • Exclude other possible causes of neurologic worsening or acute hemodynamic instability.
      • Check STAT labs: CBC, PT, PTT, platelets, fibrinogen and D-dimer.
      • Send blood bank sample for type and screen, cross-match and hold packed red cells appropriate to the hemorrhage volume, location, and associated symptoms
      • For uncontrolled, life-threatening bleeding, consider aminocaproic acid (Amicar) 10 g IV in 250 cc NS IV over 1 hr (note: there is a significant risk of pathologic thrombosis with Amicar).
      • For systemic hemorrhage, compress any compressible sites of bleeding, and consult appropriate additional services to consider mechanically occluding arterial or venous sources of medically uncontrollable bleeding.
    • For confirmed symptomatic hemorrhage on Head CT
      • Consult Neurosurgery for possible intervention.
      • Check STAT labs: CBC, PT, PTT, platelets, fibrinogen and D-dimer, if not already sent.
      • If hypofibrinogenemia present (< 100mg/dL) or likely to be present within 12 hours of t-PA administration, treat as follows:
      • Administer 10 units of cryoprecipitate
      • Administer 6-8 units of platelets
      • If patient is a Jehova’s Witness, call hematology to discuss use of tranexamic acid
    • If still bleeding at 1 hr (repeat head CT and re-draw labs):
      • If fibrinogen level still less than 100 mg/dL, repeat cryoprecipitate dose.
      • Consider anti-fibrinolytic: eg, aminocaproic acid (Amicar) 5gm bolus IV over 15-30 min
  • Institute frequent neurochecks and therapy of acutely elevated ICP, as needed.
  • Additional Options or considerations
    • If native platelet dysfunction is suspected due to concurrent uremia, give Desmopressin 0.3mcg/kg.
    • If heparin has been administered in the past 3 hours:
      • Discontinue the heparin infusion and order Protamine sulfate. Calculate total amount of heparin received over the preceding 3 hours.
      • If initiated within 30 minutes of last heparin dose: Give 1mg protamine per 100U heparin.
      • If initiated within 30-60 minutes: Give 0.5-0.75 mg protamine per 100U heparin.
      • If initiated within 60-120 minutes: Give 0.375-0.5mg protamine per 100U heparin.
      • If heparin stopped greater than 120 minutes ago: Give 0.25-0.375 mg protamine per 100U heparin.
      • Give by slow IV injection, not to exceed 5mg/min, with total dose not to exceed 50mg.
      • Monitor for signs of anaphylaxis; the risk is higher in diabetics who have received insulin.
      • Follow-up with STAT PTT q1 hour for the next 4 hours, then q4 hours through 12 hours of hospitalization.
    • Serious systemic hemorrhage should be treated in a similar manner. Manually compress and compressible sites of bleeding, and consult appropriate additional services to consider mechanically occluding arterial or venous sources of medically uncontrollable bleeding.
  • For Allergic reactions
    • If mild, eg rash, itching:
      • Immediately stop the t-PA infusion
      • Administer diphenhydramine (Bendaryl) 25-50mg IV x 1.
      • Consider steroid, i.e., hydrocortisone 100mg IV x 1 (or methylprednisolone dosepack (Medrol Pak) dose pack, if patient can take PO)
      • Nebulization if bronchospasm (uncommon)
    • If moderate or severe, eg facial or lingual swelling, anaphylaxis, etc:
      • Immediately stop the t-PA infusion, alert the ED team
      • Administer epinephrine (Epipen(R) 0.3mg in 0.3ml) IM (or if severe Epinephrine IV)
      • Bolus 1-2L NS rapidly
      • Supplement oxygen. The patient may require intubation. Facilitate respiratory evaluation and securing the airway
  • Coordinate care with accepting CMF team resident
  • tPA patient info sheet

    View sheet (PDF)

    References

    1. Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Peripheral Vascular Disease; Council on Clinical Cardiology. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Mar;44(3):870-947. doi: 10.1161/STR.0b013e318284056a. Epub 2013 Jan 31.
    2. Albers GW, Amarenco P, Easton JD, Sacco RL, Teal P. Antithrombotic and thrombolytic therapy for ischemic stroke: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):483S-512S.American Heart Association. Guidelines for Cardiopulmonary Resuscitation Emergency Cardiovascular Care. Circulation. 2000, 102 (suppl I): I-1–I-384.
    3. National Institute of Neurological Disorders and Stroke Symposium. Improving the chain of recovery for acute stroke in your community: task force reports. Bethesda, MD: National Institutes of Health, Department of Health and Human Services; 2003.
    4. Marler JR, Jones PW, Emr M, eds. Setting New Directions for Stroke Care: Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke. Bethesda, MD: National Institute of Neurological Disorders and Stroke; 1997
    5. Bock BF. Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke: Response System for Patients Presenting With Acute Stroke. http://www.ninds.nih.gov/news_and_events/proceedings/stroke_proceedings/bock.htm. Accessed August 23, 2011.

    Authoring Information

    Reviewed/Approved by: Rost, Natalia, M.D., M.P.H. on behalf of ASQT

    Last updated: 1/16/2015

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