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He was a nice guy, unmarried, living alone, and had no close family. Lucky I say because as you pointed out, they are a smart bunch and also I found a very nice bunch.

But if you raise these with them, it is as if you have said something offensive about their mother! I agree with the above concerns that there is not enough evidence to justify this as standard practice — and this policy puts us in an awkward position.

My message to the neurologists is that the data is the data and we should not be afraid if it does not happen to show what we hoped it would show.

I think they bring a bias to the table and have performed some statistical jiggery-pokery in the case of IST3 to make the results look better than they are.

I am also concerned about the closeness of the pharma industry in all of this and their involvement with the trials and the senior people who are involved in running them.

Equally as EPs though we need to be unbiased about this. The answer lies somewhere in between. Either way it seems that there is really good discussion and debate on this at EM conferences and in the FOAMed blogosphere mostly among emergency physicians.

But the 2 in my experience rarely seem to meet. I agree that when I have attempted to have sensible discussions on this with my very nice and very smart neurological colleagues, the response has universally been anecdotal stories about the Lazarus effect rather than a real discussion around the data.

So…we need better stories! To set the scene we have a large active stroke service in inner eastern Melbourne but no neurosurgical service on site.

Ambulance services in Victoria have been a part of the state health department stroke initiatives particularly in ensuring transport to stroke centres for stoke unit care and to minimise time to thrombolysis.

Unfortunately this also often includes clear cut neurosurgical emergencies like the hypertensive 50 year old man with sudden onset headache, vomiting and altered conscious state.

A number of these patients, who were certainly never going to benefit from tPA, have done poorly which may have been preventable with reduced time to neurosurgical care.

Yes we do try and divert them when they are called in as stroke signals!! Especially the young previously well clearly candidates for neurosurgical care.

Hopefully increased awareness of the evidence, or lack of it for tPA, will help at the higher level discussions previously dominated by enthusiastic neurologists, to at least enable some discretion in our situation.

This is probably an anomalous situation due to the location of our services, but serves as an example of how the evidence, if used in a rigid manner with no common sense and can result in bad outcomes.

This is probably an anomalous situation due to the location of our services, but serves as an example of how the evidence, if used in a rigid manner with no common sense can result in bad outcomes.

The rest of you already made just about every good additional point you could ever think of too. So, I only have one thing to add which is to disagree that the experts in a field in this case neurology necessarily have the best judgment on these issues.

I think EM docs on this particular list foamed followers are as likely to have read and understood the literature in question, especially with respect to NNT.

EM physicians lack the conflicts and are equally capable of interpreting the evidence. You have summarised this most eloquently. The time sensitive nature of consent for tPA is also problematic for me — with other similarly fraught procedures in similar populations — proximal femoral fracture surgery, for example — there is the time to think about the decisions, discuss them with relatives and for medical roblems to be corrected — we have none of these in acute stroke.

I tend to practice my granny medicine. Would I want tPA for my 82 year old granny? As regards my personal choice? At 37, if I had a dense dominant hemispheric stroke, probably.

The main harm of adrenaline in cardiac arrest is ROSC without subsequent good functional recovery, and all the resource intensive ICU care that ensues, including the unmeasurable harm to relatives etc.

If the benefits are clear, then we can consent for that and wear occasional bad outcomes in the business of a high-stakes game.

But the benefits are at best not clear, and the harms are undeniable. AliG makes a great point re consent and competency issues.

That being said, I do believe that most Neurologists believe that they are helping patients. But some smart people who question the evidence behind tPA seem to make compelling arguments!

I do make sure to be present during consent, to encourage the Neuro guys to be complete. And I specifically ask patient or NOK about their wishes re.

I also point out that if ICH does occur, there is little that can be done except to stop the infusion and see what happens.

I think the consent process the Neuro chaps use needs to mention that, if the side effect does occur, it is pretty much curtains. As an aside, I have also found that when engaging proponents in a discussion about the evidence base, it often ends in a Lazarus anecdote.

I tend to resist pointing out the cases I am aware of that ended in bleeding and death and disaster — but I do mention that if a population-wide intervention is best advocated by admittedly nice success stories, then things may need a rethink.

Michelle et al, thankyou for this stimulating discussion as it has made me go over the whole issue and consolidate my views on it. I even went so far as calling up my brother in Adelaide who is a consultant general medicine physician at one of the major teaching hospitals.

He says his neuro colleagues run a strokelysis protocol along with the ED service and it is pretty much standard of care in his shop. There does not appear to be concern amongst the internal medicine service there as to the merits of a stroke lysis protocol.

I put this to you all to consider. The next time you are running a cardiac arrest code and asking for the tenth dose of adrenaline to be given, if someone current with the latest resuscitation evidence, challenged the notion of giving adrenaline at all, would you quote the occasional Lazarus anecdote you have witnessed or lay the claim that it is standard of care and you are not going to change until you see better evidence?

Ultimately it comes down to selecting that right subgroup — which as yet — from the current data — is still yet to be decided.

This is an approved therapy … It is not even off licence use Sure we need to keep the research up It is standard of care for ischemic stroke just like adrenaline is in ALS.

Asystolic people may have nothing to lose or gain from adrenaline, but I am uncomfortable in stretching this to justify lysis en masses. Dear Michelle and all the other folks thank you so much for the debate!

This will come up and I think might cool down the debate which is fruitful. In a mature and developed system such as yours, it sounds as though you are indeed finding the subset of patients that do well from thrombolysis.

What would happen if fairly good evidence came out that showed definite harm? I suspect there are few truly open minds in either camp and we would be fighting people who want to protect their reputations aggressively.

Secondly, regarding the consent issue — Although neuro do the consent, I think we can stipulate that they use OUR standard proforma when obtaining that consent in our ED.

So we can be sure at least the registrar doing the consent gets the paucity of evidence and maybe even the patient and their family.

Michael Tymianski has stated that neuroprotection trials have failed in humans that worked in rodents. That is where I think the money for research should go.

Especially since its now been proven that mouse inflammation does not have same factors as humans. Like with any intervention, my approach is to let the relatives decide through a careful explanation of the situation.

Advocate strict criteria use of the NINDs criteria i. If these are deviated then I explain that the estimations will be inaccurate and can increase the risk: I would find a table such as this helps explain the probabilities and ranges assuming average NIHSS Noting that meta-analysis of all stroke trials would indicate one less green box and one more red box.

Your email address will not be published. This site uses Akismet to reduce spam. Learn how your comment data is processed. The Evidence As proponents and partakers of the FOAMed paradigm, I have no doubt that you have all had the opportunity to digest the opinions of the Titans regarding the journey that the use of thrombolytics has taken in the therapy of acute CVAs.

The Third International Stroke Trial: How is more negative evidence being used to support claims of benefit: Almost all of them carefully dissect the data and conclusions drawn from the totality of trials investigating the utility of thrombolysis in acute stroke, and feel that the summaries and recommendations by the authors do not stand up to the highest level of scientific scrutiny particularly in regard to the most recent, and largest trial, IST-3 For reference, the IST-3 paper is included here, the comment published in the same Lancet journal edition and the current Cochrane Review on the subject.

The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke the third international stroke trial [IST-3]: BUT where are we left currently??

On the damned fence! FOR — this being a position of wisdom, sense and perspicacity There may not be any clear evidence for or against, therefore coming out punching on one side or the other may prove to be utterly incorrect come the next major definitive trial and a reversal insert sense of optimism here It is not appropriate to fight this out over individual patients — it is tough enough to try and practice beneficence, without showing the patient that this may be in doubt The neurologists are a smart bunch — it is presumed that they feel the data ought to be interpreted in the best interests of the individual and the population FOR — this being a position of pusillanimity and possibly cowardice If you strongly believe that harm can be done to your patient, would this not be the time to intervene, or perhaps you may be less likely to identify those patients who the Stroke Team may consider for lysis?

By being complicit in a system that prioritises these patients for acute thrombolysis, are you not possibly diverting resources away from other patients, in the community, in the pre-hospital setting and the Emergency Department?

CT perfusion scans may be a far greater diagnostic and stratifying tool than we have presently. It seems a difficult jungle to navigate at this time.

Please add comments, join the discussion although quantum mechanics purists, consider your retribution comments pre-empted I am seriously looking forward to conversations at the upcoming extraordinary conferences And my final word?

Comments Michelle you have so neatly summarised many of the issues around stroke thrombolysis. Makes sense now Regards et al. Will be even better with an Irish accent!

You only want me for my dulcet Nordy tones, then, Chris! Of course we will get it wrong from time to time, but thats ok. Thanks Michelle et al I too am conflicted on this….

So, what does this all mean? Indeed, when added into the systematic review, IST-3 brings several of the previously significant benefits back into the nonsignificant range.

As with any major stroke trial, many of the investigators have financial associations with Boehringer Ingelheim. We know that all stroke patients will die, just as all people reading this comment will die.

If an intervention affects mortality, eventually that effect will wane as patients age because the outcome of death is inevitable.

Generally, the further we travel in time from the randomization point, the less effect we can expect an intervention to exert on an inevitable outcome like mortality.

And correspondingly, the closer in time to the randomization point, the more responsible we would expect the intervention to be for such an outcome.

Additionally, the older the studied population the sooner we would expect mortality curves to approximate. Percent dead mortality measures were performed at 7 days and 6 months.

The temporality argument warns us about a high mortality rate early despite approximation of mortality curves late.

The eye-test does too: As death is inevitable, mortality measures are in actuality only a gauge of the delay of death.

A more telling statistic than percent dead at a point in time would be days of survival during a given time period. We do not have this data from IST-3, but if we extrapolate 7-day data, we can imagine the placebo group to have survived a significantly greater number of days than the tpa group during the study period.

If we use only the data from IST-3, it seems we would be obligated to inform our patients in the face of their emergent tpa decision, that stroke is bad, that 1 in 4 patients can expect to be dead in 6 months, that if we do nothing your chance of death within a week is 1 in 14, and that if we administer tpa it is 1 in 9.

To designate the intervention as harmful requires acceptance of an assumption, that death is undesirable.

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