Intravenous TPA is the only FDA-approved therapy for acute ischemic stroke, based on the pivotal NINDS TPA Stroke Study. The drug is now approved in North America, Europe, and Japan for treating acute ischemic stroke. In the USA, IV TPA has been utilized for over a decade, and numerous meta-analyses and post-marketing studies confirm that, if guidelines are adhered to, there are substantial benefits and the risks are minimized. On the other hand, if these are violated, then the risks begin to outweigh the benefits.

Having given this cautionary statement, there is some variability in how strictly the published exclusion criteria are applied in practice at our own center. For the most part, the following indications and contraindications follow published guidelines. We have indicated beneath each guideline where we might allow some flexibility in interpreting these criteria.

TPA indications

• Age 18 or older – There are no data to guide treatment in children. However, there are case reports of older children being treated with TPA using adult criteria.

• Clinical diagnosis of ischemic stroke causing a measurable neurological deficit – Stroke must be of more than minimal severity (in almost all cases, NIH stroke scale score ≥ 3). We use the criterion, “Would it be disabling if the deficit were to persist?”

• Onset of stroke symptoms well established to be less than 180 minutes (3 hours) before treatment would begin – We have addressed the importance of establishing the time of onset in Chapter 2.

Strong contraindications

• Symptoms minor or rapidly improving – This is one of the most difficult decisions in treating patients with TPA.

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