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When tPA Should Never Be Given For A Stroke

Older gentleman with animated disappearing head

Tissue plasminogen activator (tPA) has helped save thousands of stroke victims since its approval by the U.S. Food and Drug Administration (FDA) in 1996. From the time of its introduction, there has been caution (some would argue too much caution) regarding the window of opportunity that medical professionals have to administer tPA. Currently, that window is 3 hours, which means doctors can administer tPA if the patient arrives and is ready to be given tPA within 3 hours of when they had the stroke (4.5 hours for patients who fit a certain exception).According to the Centers for Disease Control and Prevention (CDC), there are more than 795,000 stroke victims annually, and as of 2018, 1 in every 6 deaths from cardiovascular disease was due to stroke. Most of these strokes are defined as ischemic, meaning that an artery is blocked by a blood clot, causing the attack on the brain (i.e., a stroke). For many stroke victims, especially those over age 65, this means a reduction in mobility. The drug tPA can bust up the clots to restore blood flow, thereby saving precious brain tissue. So why not give every stroke victim tPA? The reason is that tPA is a powerful blood thinner, and with that comes a risk of bleeding inside the brain.

When NOT to Administer tPA?

For the 3 to 4.5 hours from the moment of the stroke, the benefits of tPA outweigh the risk. Studies show that after that window, the benefits of tPA drop significantly. Another factor that should be taken into consideration is the presence of a very large blood clot. According to a 2016 article in Scientific American:

“Of all of tPA’s drawbacks, the most troublesome is its inadequacy against big clots, which can block large blood vessels at the base of the brain; they cause about 25 to 30 percent of all strokes. Although it works well against smaller clots in narrower vessels, a safe dose of the drug—which is delivered intravenously—often does not last long enough in the bloodstream to dissolve the big clots, and increasing the dose raises the risk of bleeding.”

Other Contraindications for tPA

The National Center for Biotechnology Information lists the following criteria as contraindications for tPA therapy, according to the American Heart Association:

  • Significant head trauma or prior stroke in the previous 3 months
  • Symptoms suggest subarachnoid hemorrhage
  • Arterial puncture at a noncompressible site in the previous 7 days
  • History of previous intracranial hemorrhage
  • Intracranial neoplasm, AVM, or an aneurysm
  • Recent intracranial or intraspinal surgery
  • Elevated blood pressure (systolic greater than 185 mmHg or diastolic greater than 110 mmHg)
  • Active internal bleeding
  • Acute bleeding diathesis, including but not limited to
  • Platelet count less than 100 000/mm^3
  • Heparin received within 48 hours, resulting in abnormally elevated aPTT (activated partial thromboplastin time) above the upper limit of normal
  • Current use of anticoagulant with INR greater than 1.7 or PT greater than 15 seconds
  • Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (e.g., aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
  • Blood glucose concentration less than 50 mg/dL (2.7 mmol/L)
  • CT demonstrates multilobar infarction (hypodensity greater than a one-third cerebral hemisphere)

There is no direct way to reverse the major bleeding that may occur during tPA therapy. It’s a gruesome outcome more than just a run-of-the-mill side effect. “All you need to see is one intracranial bleed from tPA, and you realize you’ve got to pause before you give that medication,” says Thomas Maldonado, a clot specialist at New York University’s Langone Medical Center, as told to Scientific American.

When tPA Can Be Administered

Most strokes (ischemic) result from blood clots moving to a brain artery and blocking blood flow to that area. For these medical events, thrombolytics can be used to help break down the clot rapidly. Giving these drugs within the recommended time frame following the emergence of initial stroke symptoms can help limit damage and disability. The decision to administer the medication is based on the following:

  • A brain CT scan to ensure bleeding wasn’t present
  • A physical exam that reveals a significant stroke has occurred
  • The patient’s medical history

Also, a clot-dissolving drug isn’t typically administered if the patient has one or more of the aforementioned medical issues. Also, thrombolytics should not be given to a stroke patient experiencing brain hemorrhage because increased bleeding could worsen the stroke.

Risks

Bleeding is the most common risk and can be life-threatening. Minor bleeding from the gums or nose occurs in some individuals who receive tPA. Bleeding in the brain is relatively rare but can be severe and lethal.

If thrombolytics are deemed too dangerous, other potential treatments for clots causing a stroke include thrombectomy (clot removal), or carotid angioplasty, a procedure that opens clogged arteries that supply blood to the brain.

Establishing a Medical Malpractice Claim for tPA Treatment

Medical malpractice occurs when a healthcare provider fails to perform up to an established standard of care or the level of care that another healthcare professional would offer under similar circumstances.

Four main elements must be present to prove that medical malpractice occurred, which include the following:

  • Duty of care: There must be an established patient-doctor relationship in which the healthcare provider owed the patient a duty of care.
  • Negligence: The claimant must prove the healthcare provider was negligent and violated their duty.
  • Causation: The claimant must demonstrate that the healthcare provider’s negligence caused their injuries.
  • Losses: Damages represent the compensatory losses the victim suffered because of medical malpractice. 

Economic Damages

Economic damages cover the quantifiable expenses that medical malpractice causes. Although there may be some guesswork involved, such as when it comes to future medical expenses, these damages are typically more precise than non-economic damages and may include the following:

  • Medical expenses, such as emergency care, hospitalization, doctor’s visits, surgeries, therapies, etc.
  • Lost past and future income, diminished earning capacity
  • Costs of at-home care or assisted living

Non-Economic Damages

Non-economic damages refer to intangible losses related to the victim’s quality of life and, therefore, cannot be calculated using bills and receipts. The most common examples include the following:

  • Loss of life enjoyment
  • Physical pain and suffering
  • Emotional anguish
  • Loss of companionship
  • Permanent disability
  • Scarring and disfigurement

Each case is unique, so there are no set rules regarding how the exact amount of damages is determined. However, the patient, their loved ones, and experts can provide evidence about their pain and suffering, loss of life enjoyment, etc., to arrive at a dollar value. 

There is a cap or maximum amount for non-economic damages in Maryland that increases by $15,000 each year. For personal injury claims (including medical malpractice) that arise after October 1, 2021, that amount is $905,000.

Have You or a Loved One Suffered From Medical Malpractice After a Stroke? Contact Us Today

Strokes are serious medical events that require prompt and accurate treatment, and sometimes that may include administering tPA. But, as we have noted, tPA is not appropriate for all strokes. If you suffered a stroke and your physician either did not administer the proper treatment or administered a treatment incorrectly, our Baltimore medical malpractice attorneys can determine whether you have a case. You may be entitled to significant compensation for medical bills, lost wages, and more. 

Call us today for a free consultation so that we can review your situation and advise you on your legal options and how you might be able to recover full compensation for your injuries and losses.

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