Thrombolytics and stroke

Clot-busters for acute stroke is one of the more controversial interventions. Normally, the recommendation is for a 3-hour window between drug and onset of symptoms.

A recent study suggests that this can be lengthened to 4 1/2 hours.

There is no mortality benefit to using thrombolytics.

The downside is the not insignificant risk of bleeding leading to neurological complications, which malpractice attorneys are taking advantage of. It was 2.4 percent in the reported study.

It is because of the risk of being sued that emergency physicians are gun-shy about using the drug.

One answer? WhiteCoat suggests immunity:

If an emergency physician gets a CT report from a radiologist that says “no bleed,” the patient meets the criteria for thrombolytic therapy and doesn’t have any exclusion criteria, then the emergency personnel cannot be held liable for any bad outcomes for giving thrombolytics.

That’s an extreme measure, and unlikely to happen. However, if the public demands increased clot-busting use in stroke, that’s what it may take to convince some doctors to use them.

It’s better to emphasize to patients about the very real risks of thrombolytics for only potentially marginal benefits that do not impact mortality.

Let the patients decide.

Comments

David
A couple of points:
(1) Under the right circumstances, always give me a drug (like IV TPA) that does not increase my risk of death but does increase my chances of having a better neurological exam.
(2) The last I checked, there were many more lawsuits related to NOT GIVING TPA when appropriate, than the other way around.
(3) Neurologists are the experts in this area and need to be called when a possible TPA case comes through the door. In my hospital, a specially trained team of nurses expedites the head CT and labs, and contacts the neurologist with the story and with the results of a standardized neurological exam (NIH Stroke Scale). The TPA order can be given by the neurologist over the phone.
Anonymous
I cared for a young woman who developed a bad brainstem stroke from fibromuscular dysplasia. Languished in ER, no thrombolytic given. Her neurologist (who came onto the scene long after) told me she was a perfect candidate. Believe me everybody got sued. As they should have. A tragedy all around.
judd
David:
1. “positive” studies get all the hoopla and publicity and lay press coverage. What you don’t hear about are all the negetive studies when this is taken out to the community
2. This study was sponsored by the drug manufacturer, therefore you should be highly skeptical.
3. It is not surprising that there are more lawsuits for not giving since only about 1-3% of stroke patients get it. The denominator of those not getting it for whatever reason is about 50 times greater.
4. You are lucky to have a stroke team. Most don’t and don’t have the resources to do so.
ANON 4:21
The neurologist is an ass for:
1. Strolling in way after the fact, after time has passed, more tests are done and then saying “such and such” should have been done. Where was he initially?
2. Stating that she was the perfect candidate. A young woman having a brainstem stroke from “fibromuscular dysplasia” is going to be a ver very unusual presentation. I guarantee you there is no data that specifically supports tpa in that tiny unfortunate subset.
3. Everyone got sued probably because or what the neurologist said and because there wasa bad outcome, not because of merit.
4. Does your hospital have a stroke team? Neurologists willing to take emergency call and come to the ER withinn 30 minutes? Have neuroradiologists reading the head CT? have a specific neurological ICU?
David
Judd,
You are right on with your comments. I am aware of the ‘Cleveland area experience’ in which IV-TPA patients experienced a large number of intracerebral hemorrhages. It was found that a number of violations of protocol were probably the cause including patients being treated despite having uncontrolled hypertension or an unclear time of onset of stroke symptoms. With this in mind, the Cleveland area hospitals revamped their approach and became more stringent with regard to when they would administer TPA. The result was an essentially identical outcome to the original NINDS study (better neuro outcomes, no significant change in mortality).
I think TPA has been a large learning experience for all involved. As with many medications, initially it wasn’t known how rapidly it had to be given, or that blood pressure was a significant issue, etc.. Each study built upon the previous one. In addition, as with most medications, use in the community was ‘widened’ outside the scope of treatment supported by the NINDS trial. Now it has been realized just how ‘touchy’ IV-TPA can be.
With regard to lawsuits, you’re analysis is probably the right one. It should be born in mind, though, by ER physicians and anyone else treating an acute stroke patient, that there is no ‘safety’ in not giving the medication. It is better to do the assessment and give the drug *when indicated*, from this perspective at least.
JUDD
David:
Agree.
The combination of drug company promotion/lay press sensationalism/patient expectationalism/trial lawyers has made this perhaps one of the most distateful aspects of EM practice.
I work at a very very busy community hospital that is a trauma and cardiac center yet for strokes I do not have:
1. neuroradiologists reading CT
2. neurologists willing to come in and put themselves on the line
3. A stroke team
My heart sinks every time I see a stroke. I give the family a handout trying to explain NINDS, risks and benefits of tpa, as well as limitations of my hospital. Whenever possible I have the patient and family sign an informed statement whether they decide to proceed or withhold tpa. It is often questionable whether a patient having a stroke has the ability to even comprehend and make an informed decision.
My partners have been sued for giving and not giving. Either way it is extremely time consuming and other patients in the department probably get ignored because of the investment of attention it requires.

Thrombolytics and stroke

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