CHECKLIST: tPA Eligibility Criteria + sample consent form

From ENLS / ACC/AHA 2013

Eligibility

  • Diagnosis of ischemic stroke causing measurable neurological deficit. Neurological signs should not be minor and isolated. Neurological signs should not be clearing spontaneously
  • Onset less than 3 h before initiating alteplase
  • Patient is at least 18 years old (see section on special considerations: pediatric stroke)

Absolute exclusion criteria if positive

  • No major head trauma or prior stroke in the previous 3 months
  • Symptoms of stroke should not be suggestive of subarachnoid hemorrhage
  • No arterial puncture at a non-compressible site or lumbar puncture in the previous 7 days
  • No history of previous intracranial hemorrhage
  • No history of intracranial neoplasm, aneurysm, or arteriovenous malformation
  • No intracranial or intraspinal surgery in the previous 3 months
  • Blood pressure not elevated (systolic <185 mmHg and diastolic <110 mmHg)
  • No evidence of active bleeding or acute trauma (fracture) on examination
  • Platelet count <100,000 mm3
  • If receiving heparin in previous 48 h, aPTT must be in normal range
  • Not taking an oral anticoagulant or, if anticoagulant being taken, INR < 1.7 or PT > 15 s
  • No dabigatran, apixaban, or rivaroxaban use for chronic anticoagulation for conditions such as atrial fibrillation. There is still little information on assessing influence or levels of these medications in patients with acute stroke. There are suggestions to check an activated thromboplastin time (aPTT), INR, platelet count, thromboplastin time (TT), ecarin clotting time (ECT) and anti factor 10a level (if available). Without normalized special tests (as listed), use of alteplase is NOT recommended in patients with recent use (within 48 h) of these products
  • Blood glucose concentration <50 mg/dL (2.7 mmol/L)
  • CT does not show a multilobar infarction (hypodensity >1/3 cerebral hemisphere)

Relative exclusion criteria if positive—use caution if recommending alteplase if one or more are positive

  • Stroke symptoms are rapidly improving or only minor
  • Pregnancy
  • Seizure with postictal residual neurological impairments
  • Major surgery or major trauma in the previous 14 days
  • Gastrointestinal or urinary tract hemorrhage in the previous 21 days
  • Myocardial infarction in the previous 3 months

Some additional considerations

  • Caution should be exercised in treating a patient with major deficits
  • Caution using alteplase in patients treated with low molecular weight heparin in the past 24 h
  • Patient or family members understand the potential risks and benefits from treatment. No written consent is required but the conversation should be documented in the clinical notes. Do not delay IV therapy if a surrogate is not readily available as this can lead to worse outcomes
  • Alteplase is not FDA approved for treatment of patients under the age of 18. However, alteplase has been used off-label in selected pediatric patients with strokes, following careful counseling of parents and using identical eligibility and contraindication criteria to those used in adults.

================

Inclusion criteria

  • Clinical diagnosis of ischemic stroke causing measurable neurologic deficit
  • Onset of symptoms <4.5 hours before beginning treatment; if the exact time of
  • stroke onset is not known, it is defined as the last time the patient was known to be normal
  • Age ≥18 years

Exclusion criteria

  • Historical
    • Significant stroke or head trauma in the previous three months
    • Previous intracranial hemorrhage
    • Intracranial neoplasm, arteriovenous malformation, or aneurysm
    • Recent intracranial or intraspinal surgery
    • Arterial puncture at a noncompressible site in the previous seven days
  • Clinical
    • Symptoms suggestive of subarachnoid hemorrhage
    • Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg)
    • Serum glucose <50 mg/dL (<2.8 mmol/L)
    • Active internal bleeding
    • Acute bleeding diathesis, including but not limited to conditions defined in ‘Hematologic’
  • Hematologic
    • Platelet count <100,000/mm3*
    • Current anticoagulant use with an INR >1.7 or PT >15 seconds*
    • Heparin use within 48 hours and an abnormally elevated aPTT*
    • Current use of a direct thrombin inhibitor or direct factor Xa inhibitor with evidence of anticoagulant effect by laboratory tests such as aPTT, INR, ECT, TT, or appropriate factor Xa activity assays
  • Head CT scan
    • Evidence of hemorrhage
    • Extensive regions of obvious hypodensity consistent with irreversible injury
  • Relative exclusion criteria¶
    • Only minor and isolated neurologic signs
    • Rapidly improving stroke symptoms
    • Major surgery or serious trauma in the previous 14 days
    • Gastrointestinal or urinary tract bleeding in the previous 21 days
    • Myocardial infarction in the previous three months
    • Seizure at the onset of stroke with postictal neurologic impairments
    • Pregnancy
  • Additional relative exclusion criteria for treatment from 3 to 4.5 hours from symptom onset
    • Age >80 years
    • Oral anticoagulant use regardless of INR
    • Severe stroke (NIHSS score >25)
    • Combination of both previous ischemic stroke and diabetes mellitus

<Eligibility criteria for tPA in PDF format>

Written consent is no longer required for tPA as this treatment is considered standard of care for acute ischemic stroke. That being said, the verbiage on this old consent form is a reminder of the information necessary for informed consent for tPA.

I have been clearly and fully informed by Dr._ that I am having a stroke. It has been explained to me that the Intravenous Thrombolytic Therapy using the drug t-PA, administered promptly after the onset of symptoms of a stroke may dissolve the clot and restore blood flow which may lessen the amount of damage to my brain.

I have been made aware that there are common risks and complications of Intravenous Thrombolytic Therapy as well as risks and complications of not having the therapy done. I have been told that the major risks from the use of t-PA are the possibility of internal bleeding including the stomach or intestinal tract and brain. The risk of bleeding in the brain is about 6%. If bleeding into the brain occurs my condition could worsen and may even result in death. I understand that some of the other possible reactions to t-PA include: temporary bruising or bleeding in the mouth, nose, skin, urinary tract or arm. If I refuse therapy my stroke could worsen or not improve.

I have received no guarantees as to results of Intravenous Thrombolytic Therapy. I understand that the alternative is to not receive t-PA and receive only supportive treatment.

In 1996, t-PA was approved by the Food & Drug Administration (FDA) for treatment of stroke within the first 3 hours after onset. In 2009, national guidelines concluded that this treatment could be helpful up to 4.5 hours after the onset of an acute stroke. Currently, the FDA has not approved t-PA for the treatment beyond 3 hours of symptom onset.

The nature and purpose of this therapy and the risks involved have been explained to me by the physician. I have been given an opportunity to ask any questions I may have, and all such questions or inquiries have been answered to my satisfaction. I have read this form and understand it fully.

REFERENCE:

http://www.uptodate.com/contents/image?imageKey=NEURO%2F71462&rank=1~51&search=tpa&source=image_view&view=print&topicKey=NEURO/1124&source=outline_link&rank=1~51&elapsedTimeMs=1

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