Recognizing a Potential Stroke: How to Document Medical Decision-Making Around Administering Thrombolytics, Tissue Plasminogen Activator (tPA), and Tenecteplase (TNK)

This article reviews the background around reperfusion therapy, basic diagnostic pitfalls (including awareness around sometimes difficult to diagnose posterior circulation stroke presentations), consent, and documentation. We also discuss the importance of ensuring the clinical record reflects the complex medical decision-making processes surrounding the care of potential or diagnosed stroke patients. Additionally, early consultation with a neurologist whenever a stroke is in the differential or at a time when reperfusion therapies are considered may be helpful.

The Differential Diagnosis
When diagnosing a stroke, be wary of the “atypical” symptoms of posterior circulation strokes. There may be new, lifesaving protocols for stroke patients, but an obvious and key point is that one must have a high enough index of suspicion for a stroke to start the process. Thus, diagnostic consideration of a stroke has to occur so that stroke protocols and appropriate STAT neuroimaging can be initiated. Sometimes, stroke symptoms can be “classic” such as acute facial droop, dysarthria, and extremity weakness. However, some strokes, particularly those involving the posterior circulation, can be non-specific or subtle, and mimic other common, more benign conditions. These non-specific symptoms include dizziness and vertigo, cerebellar ataxia, or headache.

Common pitfalls around these symptoms include:

• Failure to do a more thorough history around onset, severity, and exacerbating factors
• Failure to perform a more complete neuro exam and to document what was performed
• Failure to observe the patient’s gait

Sometimes, a benign condition is the overwhelmingly likely cause of symptoms. However, when a patient presents with sudden or severe dizziness and vertigo, ataxia, or headache and the provider determines that a further stroke workup is not indicated, it is important the medical record clearly outlines the history, specific positive/negative exam findings, and the provider’s thought process that led to this determination. The "HINTS" exam, which includes head impulse, nystagmus, and test of skew, may help distinguish between peripheral and central sources of vertigo. Posterior circulation strokes account for approximately 20 percent of all strokes, but they are disproportionately represented in lawsuits around allegations of delayed diagnosis. Good documentation can be key to the defensibility of the real-time decision-making process.

Time Is Brain
Once a stroke is considered as a reasonable possibility, the benefits of reperfusion are time dependent. When administered up to 4.5 hours from ischemic stroke onset, the benefits of reperfusion therapy have been shown in multiple trials, repeatedly demonstrating that the earlier thrombolytics are administered, the better the outcome. If a patient presents within the 4.5 hour time window but a decision is made to not administer tPA or TNK, then it is very important for clinicians to document the medical decision-making process that led to withholding the therapy.

The decision to not administer tPA or TNK may very well be the best care in a particular situation. In the event of significant post-stroke morbidity or death, patients or families may be confused as to why the “clot buster” therapy was not given. Clearly outlining, in real time, the thought process to not administer tPA or TNK can be illuminating on retrospective analysis and potentially protective in the event a plaintiff attorney reviews the records. Additionally, if a decision is made to administer tPA or TNK after the 4.5 hour time window, then a clear outline of this thought process should be included in the medical record because of trials showing an early increased risk of intracerebral hemorrhage when tPA or TNK is administered after the 4.5 hour protocol. As with decisions to withhold treatment, decisions to treat outside of guidelines should be clearly documented and done in real-time.

tPA, TNK, and Mechanical Thrombectomy
There is a persistent misunderstanding by some providers that recent administration of tPA or TNK will be a contraindication for mechanical thrombectomy. This is incorrect. The data suggest that patients who have acute ischemic strokes and are candidates for tPA or TNK should receive the therapy without delay. This includes patients who are being considered for mechanical thrombectomy. Clinical evidence supports that mechanical thrombectomy may follow the initial administration of tPA or TNK.

Documentation and Consent
Due to the emergent and severe nature of strokes, along with the benefit of rapid administration of tPA or TNK, the process of obtaining consent should not delay the steps of a stroke protocol necessary to administering tPA or TNK (e.g., transport to STAT neuroimaging). However, if possible, briefly discuss the risks and benefits of administering tPA with the patient, family, and/or health care proxy as part of the informed decision-making process. The discussion would likely include information about tPA or TNK reducing the risk of disability or death, the risks of serious bleeding, and the key component of timeliness in administration to ensure the best chance of a favorable outcome.

In summary, all documentation in the care of stroke patients is subject to intense scrutiny. The complex interplay of diagnostic challenges includes risks of administering and not administering tPA or TNK, as well as protocols falling outside of patient and/or family expectations. It is important that providers are aware of some of the key areas noted in this article for thorough and contemporaneous documentation including history, neurological examination performed, medical decision-making, and consent.

Information in this article is for general educational purposes and is not intended to establish practice guidelines or provide legal advice.

Article originally published in 4Q23 Copiscope.