Major changes for thrombolytic administration for ischemic strokes

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This article isn't in and of itself new changes. (More just a review of contraindications and whether there's data for them)
There's a nice appendix at the end about new FDA reqs for tpa use that is updated from last year. (Ex prior stroke in last 3 months is no longer a contraindication while elevated BP remains one, etc).
 
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Anyone else being forced into the PRISM trial at work? Now our neurologists are pushing TPA for mild neuro deficits like facial palsy, paresthesias, etc. Scary stuff.
 
GeneralVeers said:
Anyone else being forced into the PRISM trial at work? Now our neurologists are pushing TPA for mild neuro deficits like facial palsy, paresthesias, etc. Scary stuff.
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Yay! tPA for bell's!!
 
GeneralVeers said:
Anyone else being forced into the PRISM trial at work? Now our neurologists are pushing TPA for mild neuro deficits like facial palsy, paresthesias, etc. Scary stuff.
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The only good thing about that is that fake strokes/tiny strokes rarely bleed (<1%) b/c there's no big clot to bust up and bleed everywhere.
 
It's scary when the logic for giving a treatment is that it probably won't cause the person's head to explode.

How about getting some data that it works at all?
 
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When does it go generic? That is when all the crap science advocating its use will go away.

...we have to get rid of the chegs and orgo guys and girls first or they will just tweak the formula and repatent it under some other name.

I should have embraced osteopathic manipulation when I had the chance.

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" Extended Time Window The ECASS III trial, performed in Europe, included thrombolytic therapy from 3 to 4.5 hours, with the addition of 4 exclusion criteria: age >80 years, NIHSS score >25, history of diabetes mellitus and prior stroke, and taking OACs (Please see below for a description of the scientific rationale behind these additional exclusion criteria in the extended time window).4 The degree of benefit seen in ECASS III was an OR for global favorable outcome (1.28; 95% CI, 1.00–1.65). This pivotal trial led to a revision of the AHA/ASA acute stroke management guidelines, which now recommended intravenous alteplase out to 4.5 hours from symptom onset, provided that the additional exclusion criteria are followed. However, the FDA did not approve a change in indication after reviewing the trial results and unpublished data from the company that produces alteplase."

Just wondering if there were any lawsuits that keyed in on this detail.
 
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shookwell said:
neurologists are ****ing insane

they wanted to run a stroke/CT ambulance here but we told them we wouldn't let them respond to anything
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Wasn't that conclusively proven to be non beneficial? Not just that, but aren't we talking about an absurd amount of money for something that will be functional for about half the time, at best?
 
TimesNewRoman said:
Wasn't that conclusively proven to be non beneficial? Not just that, but aren't we talking about an absurd amount of money for something that will be functional for about half the time, at best?
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Yes, in Berlin, they had a super-ambulance called STEMO that responded to apparent stroke cases.
+outcome = gave TPA 25 minutes FASTER than controlled groups with standard EMS response... pretty well controlled (they did a week on / week off).
No increase in intracranial bleeds detected.

Very expensive. Does 25min earlier TPA improve outcomes? Silly for you to ask THAT question...

Even if you believe it does give MILD improvement in long term outcome, at what cost? tele-neuro in all ALS buses with TPA... can you imagine?
 
I just wish there was some kind of logic behind their madness.
NIHSS 2, based vague reports of slurred speech no objective person could quantify. Rapidly improved. >80 years of age.
Yep, give tPA.
Sigh.
 
!anecdote alert!

The 1st case of EMS-activated stroke care I saw was for an acute onset difficulty speaking.

The patient had a normal HR, BP and O2 sat, so the EMS crew appropriately activated the code stroke protocol.

The patient went straight from the ambulance to the CT scanner.

Soon after the patient was swarmed by the Neurology team and ED registration (so nobody else could get to the patient).

Neurology told my partner they needed further studies, and this was just before change of shift, so...

I came on shift and got the patient in sign out about 45-60 minutes into the ED stay. The nurse told me I'd better go take a look at the patient ASAP, because something wasn't right.

When I got into the room it was clear that the patient had epiglottis.
 
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I intend to talk all of my patients who meat PRISMS criteria out of thrombolytics. Knowing what I know about the efficicacy and risk of thrombolytics, I can't in good conscience order TPA for them. I'm ambivalent enough about thrombolytics for severe stroke as it is.

I work at a regional referral center that has 24 hour interventional neurology. It's an insane circus of ridiculousness when we get a stroke patient. I have to talk to the stroke-on-call nurse, then the stroke-on-call tele-neurologist, then the neuro-interventionalist, then the neuro-critical care doctor, and finally the primary admitting doc to get admission orders. Craziness!!
 
madness; no evidence of benefit, but spending millions on it anyway; I'd say it's the American Way but this is more prevalent in Europe, for now.

Mobile-Stroke-Ambulance.jpg
 
Old_Mil said:
" Extended Time Window The ECASS III trial, performed in Europe, included thrombolytic therapy from 3 to 4.5 hours, with the addition of 4 exclusion criteria: age >80 years, NIHSS score >25, history of diabetes mellitus and prior stroke, and taking OACs (Please see below for a description of the scientific rationale behind these additional exclusion criteria in the extended time window).4 The degree of benefit seen in ECASS III was an OR for global favorable outcome (1.28; 95% CI, 1.00–1.65). This pivotal trial led to a revision of the AHA/ASA acute stroke management guidelines, which now recommended intravenous alteplase out to 4.5 hours from symptom onset, provided that the additional exclusion criteria are followed. However, the FDA did not approve a change in indication after reviewing the trial results and unpublished data from the company that produces alteplase."

Just wondering if there were any lawsuits that keyed in on this detail.
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By definition a value of 1.0 on a 95% CI odds ratio range means that it's not statistically significant. I.e. P>0.05. Not at all surprised that the FDA saw this and said naw.
 
It's been my experience (and that of my institution) that ICH is nowhere near as prevalent as the studies indicate. Maybe it's just our patient population, but I can count on one hand the number of bleeds we've had from TPA administration over the past 2 years. I'm not sure what our average is for TPA currently, but I know I've TPA'd at least 10 this year alone (we are a comprehensive stroke center). One of my patients had a door-to-needle time for TPA administration of <10 minutes.

Despite what people may claim, the research does support its use, it does make a difference (from my anecdotal evidence), and there are nowhere near the complications reported in prior studies (at least at my health system). Don't be afraid to give it. We do far more things that can cause far more harm.

Having said that, five years from now I think all stroke patients will be treated primarily at comprehensive stroke centers with endovascular capability. The studies are clear of the benefits of early endovascular care.
 
southerndoc said:
Having said that, five years from now I think all stroke patients will be treated primarily at comprehensive stroke centers with endovascular capability. The studies are clear of the benefits of early endovascular care.
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Maybe. If you're lucky enough to live near one of those centers. But they had 15 years of failure before finally showing some benefit in the last year or so.

10 years from now tPA administration will look like the the NACSCIS trials. Minimal benefits, huge costs, lots of problems after the fact.
 
southerndoc said:
Having said that, five years from now I think all stroke patients will be treated primarily at comprehensive stroke centers with endovascular capability. The studies are clear of the benefits of early endovascular care.
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I disagree with your last statement. There are a few biased studies with methodological flaws that show benefit, in the setting of multiple prior studies showing harm. It may be that the newer devices are better, or patient selection was better, but it's hard to say from what was published. The data is far from clear. Having said that, I do think that the neurology and industry interest groups will be successful in pushing this (insanity) onto us without much more data. It has already started. I just hope that we aren't going to be harming too many patients in the process.
 
I don't think tpa is pure evil.
I just don't think it's use is supported by the data currently available.

It probably has benefit for some patients.

My problem isn't so much tpa itself, it's all the resources that get directed towards stoke evals in a mad dash to give a therapy that is unproven.

It drives me nuts when other sick patient's care is delayed due to stroke evals taking priority.
 
gman33 said:
I don't think tpa is pure evil.
I just don't think it's use is supported by the data currently available.

It probably has benefit for some patients.

My problem isn't so much tpa itself, it's all the resources that get directed towards stoke evals in a mad dash to give a therapy that is unproven.

It drives me nuts when other sick patient's care is delayed due to stroke evals taking priority.
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Exactly this. I view TPA use for stroke as I would for PE. Give in the case of catastrophic, life-threatening ischemic stroke. The "Code Strokes" that we call on anyone with a bit of numbness, tingling or slurred speech is pure insanity, and probably negatively impacts the care other patients receive.
 
gman33 said:
I don't think tpa is pure evil.
I just don't think it's use is supported by the data currently available.

It probably has benefit for some patients.

My problem isn't so much tpa itself, it's all the resources that get directed towards stoke evals in a mad dash to give a therapy that is unproven.

It drives me nuts when other sick patient's care is delayed due to stroke evals taking priority.
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I'm a neurology resident, and we're not all insane. I agree with this 100%.

Most of the time I get to the ER, and the ER resident/attending tells me the story and we just look at each other, because neither one of us thinks it's a stroke, but they were forced to call a stroke code, and I was forced to drop whatever I was doing to respond. I've gone to hundreds of codes, and can count on two hands the number of times I've given TPA (when a stroke attending wasn't present and forcing me to give it). At my very large urban hospital, the vast majority of patients don't show up within the window, yet we're forced to direct all of our resources to shave 7 minutes off of the door to needle time in the very few patients who are potential candidates.

I'm about to graduate, and the number of times I've given TPA is less than the number of times some residents have given TPA in a given month. They have a lot of MRI negative strokes. I can't embrace this idea that we should be giving a 2,000-10,000 treatment to pinky tingling just because there's no evidence that we shouldn't.
 
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tPA for clearance of intraventricular extension of hemorrhagic stroke.

It's been tried a few times.

I've only seen the abstract from ISC16, but the problem with previous studies was mostly dramatically increased incidence of ventriculitis. I wonder if the control group shouldn't have omitted their saline injection, but I'd have to see the final paper for full methods.

The more annoying thing I've seen over the last few years is Genentech jacking the price up for alteplase. Their many years of hard work entrenching its use into various quality measures and the insanity of our stroke alerts has come to fruition.
 
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