Criteria to Give tPA for Stroke

tPA for ischemic stroke was first approved in 1996 based on the result of two NINDS studies that compared outcomes of placebo or IV tPA given in the first 3 hours of a stroke.

The studies found that tPA improved outcomes for 1 in 3 patients (number needed to treat = 3 for improvement compared to placebo) and allowed for recovery of near-normal function for 1 in 8 patients (number needed to treat = 8 for near-normal function).

The major side effect of tPA was brain hemorrhage and caused a worse outcome in about 1% of patients.

The longer the delay between the onset of symptoms and the administration of tPA, the less recovery is likely. Time is brain.

Most major hospitals have a customized protocol that sets out their criteria for administering, or not  administering, tPA for CVA. The following is list of the most common criteria.

Inclusion criteria

    • Patient presents within 3 hours of the onset of symptoms. This usually means the patient must have been observed to be normal less than 3 hours from presentation.
    • Focal neurological symptoms are present. If symptoms resolve spontaneously (i.e. T.I.A.) tPA is NOT indicated.
    • Patient is at least 18 years old.
    • A CT scan, read by a qualified physician, has shown no hemorrhagic stroke.

Absolute exclusion criteria

  • Intracranial hemorrhage on non-contrast head CT
  • History of hemorrhagic stroke or other intracranial hemorrhage, AVM, intra-cranial neoplasm or aneurysm
  • Suspicion of subarachnoid hemorrhage despite normal CT
  • CT evidence of CVA affecting more that 1/3 of MCA territory (multi-lobar infarct)
  • Uncontrolled hypertension (sBP>185 or dBP>110) despite appropriate attempts to control blood pressure
  • Seizure at the onset of stroke that, because of residual post-ictal deficits, may mask underlying neurological status
  • Pregnancy
  • Tendency to have acute bleeds, with risk factors including:
    • Platelets < 100,000/mm3
    • Heparin in the previous 48 hours with PTT > 40
    • Currently on anticoagulant (eg. coumadin; some criteria include INR > 1.7, others do not have an INR cutoff)
  • Other bleeding risks:
    • Head or spine surgery within the prior 3 months
    • Head trauma within the prior 3 months
    • CVA within the prior 3 months
    • Arterial puncture at noncompressible site within last 7 days

Relative exclusion criteria

  • Severe neurological deficit (NIH stroke scale > 22) or mild deficits (NIH SS <4 with no dysphasia) or spontaneous rapid imrpovement
  • Trauma or surgery within the last 14 days
  • GI bleed or urinary tract hemorrhage in the previous 21 days
  • Acute MI in the previous 3 months
  • Dressler’s Syndrome (post-MI pericarditis)
  • Hypoglycemia (BS < 50) or Hyperglycemia (BS > 400)
  • History of both diabetes and ischemic stroke(s)


Hacke W, Donnan G, Fieschi C, Kaste M, von Kummer R, Broderick JP, et al. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. Mar 6 2004;363(9411):768-74.

Albers GW, Clark WM, Madden KP, Hamilton SA. ATLANTIS trial: results for patients treated within 3 hours of stroke onset. Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischemic Stroke. Stroke. Feb 2002;33(2):493-5.

Example hospital tPA checklists can be found at:

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About the Author: Naoum P. Issa MD PhD