When trauma patients arrive at hospital with multiple
injuries and haemodynamic instability (significant blood loss, low blood
pressure, increased risk of dying), apart from resuscitating them (usually by
giving blood and other things like clotting factors) the treatment is summed up
by the phrase: “Stop the bleeding”.
“Stopping bleeding” is a biologically plausible mechanism
for saving life that I will accept on face value. My question is: do our noble
attempts to stop the bleeding actually influence the chance of dying? Looking
at previous treatments that have fallen out of favour, I would say not. And
the treatments currently in vogue are supported by as little evidence as those
they replaced.
Now I know there are other outcomes apart from death, like
organ failure, infection, quality of life, time in intensive care etc., but
with patients like this, your main aim is really to keep them alive and to sort
out the rest later. So what can we do? Read on, or skip to the bottom line.
Splenectomy
A ruptured spleen was thought to be associated with 90 –
100% mortality without surgical splenectomy. Now up to 90% of them
are treated non-operatively – the results are better, as they don’t die, and we
now avoid all the complications of splenectomy (yes, the spleen has a purpose –
overwhelming
infections may occur without it). The history of splenectomy is provided here. Angiographic
embolization (AE) may have helped drive non-operative treatment, but I can find
little evidence that it helps (see section below on AE).
Clotting agents
Recently, there has been interest in newer clotting agents.
Factor VII is a naturally occurring clotting factor that can now be produced in
the lab (for a price - about $10,000 per patient). It makes blood clot by bypassing the other clotting
factors that often get depleted in a sick, bleeding patient. It makes sense. The
large placebo controlled
trial for Factor VII showed a (small) reduction in the need for blood transfusion,
but interestingly it had no significant effect on the overall rate of death
(the placebo group did slightly better). This is interesting because the decrease
in blood loss (or at least in blood transfusions required) was not matched by a
decrease in mortality.
The other clotting agent recently tested is tranexamic acid
(TXA). This has been shown to reduce overall mortality in trauma patients (in a
large
study of over 20,000 patients) by about 1.5%. Further analyses of this
study showed that TXA was particularly effective if it was given within 1 hour
of injury (not always possible) and that it was harmful (actually increased
mortality) if given after the 3 hour mark (here).
So while I agree that TXA may have some benefit in this situation, you will
have to admit that the benefit is not large, and that you may need to be
careful about when you give the drug.
Tourniquets
Nothing stops bleeding like a tourniquet, right? These days,
there is much talk of applying tourniquets in the field. Commonly in trauma
care things go in and out of fashion, and tourniquets were definitely out of
fashion when I did my training and they are definitely in fashion now, largely a
result of military studies from the middle east. There are plenty of studies
looking at how often tourniquets are used, what types, how long, and survival
rates (here,
here, here and here) but there are no
good comparative studies at all, not even a good before-and-after study, and
they are the best ones for showing that something works because they nearly
always show an improvement in the "after" group, no matter how ineffective the intervention.
Am I being crazy? Of course they save lives, you say. Maybe, and the lack of good evidence doesn’t mean that they don’t work. But remember, the conviction
with which tourniquets are currently being promoted is no greater than the
conviction behind all the other emergency interventions listed above and below,
and the previous call for not using a
tourniquet. A good overview of the history of tourniquet use, up to the present
day, is provided here.
If tourniquet use is going to save lives, I guess military
casualties where rapid evacuation to a controlled environment is where they
will work. Do tourniquets cause harm? Of course: from the moment you apply a
tourniquet the timer is running, and there are plenty of examples of harm from
tourniquets being too tight or left on for too long. And this assumes that you
apply it correctly, because inadequate application is associated with increased blood loss – a common problem,
historically. Without any comparative trials however, we are going to have to rely on
the opinions of the people with experience. Just don’t be surprised if that
opinion changes over time.
Replacing precious
bodily fluids
In my day, we gave copious amounts of colloid solutions
(more expensive, supposedly stayed in the bloodstream, made sense) instead of
saline-type solutions intravenously to resuscitate bleeding patients. Ends up
they made no difference the whole time (Cochrane review) and are being withdrawn in Europe (here). We
were also taught to infuse as much fluid as possible to resuscitate these
patients. Now it appears that this was harmful, and we should be performing
‘low-volume resuscitation’, also termed 'permissive hypotension' (here and here). This provides a
good example of changing the biological mechanism to fit the current thinking.
Originally it was “restore the intravascular volume by giving fluids, to keep
the blood pressure and tissue perfusion up”. Now it is “raising the blood
pressure will increase bleeding by disturbing clots ('popping the clot')”. For a more detailed review, read this.
For a more confusing account of the pathophysiology, read this.
Pre-hospital fluid resuscitation was also considered
important (again, made sense), but later prospective studies (like this one) showed that
pre-hospital fluids led to worse outcomes. Similarly for Intensive Care resuscitation, colloids don't help (here).
The MAST suit
Military Anti Shock Trousers (MAST suits) were once
considered life saving. Every ambulance in my day had one, and they were used
for most major trauma patients. The suit was wrapped around the patient’s
pelvis and legs and inflated, theoretically pushing the fluid back into the
upper (more important) half of the body to counter the shock. It was later
considered dangerous because it also pushed the abdominal contents up through a
ruptured diaphragm, blocked circulation to the legs, and in this randomised trial,
led to more deaths in the MAST suit group. The history of the MAST suit is
detailed here
and there is also a Cochrane
review. The MAST suit is no longer used.
Fixing the pelvis
External fixation (placing pins into each side of the
pelvis, and connecting them with a rod to stabilise the bones) was all the rage
when I was doing my training. It made sense (somehow, I’m sure) and people
swore that patients got better as soon as you fixed the pelvis. There are many
reports of patients getting better after pelvic fixation, and many reports now talk about
new ways of placing the external fixator (even internally), and others talk
about timing of fixation. Some papers even publish great results when they
deliberately don’t use pelvic
external fixation (here),
but without any comparative studies it is hard to say if it does anything. And
biologically speaking, I really cannot see any advantage over a pelvic binder
(a sheet wrapped around the pelvis) in the acute period.
The pelvic C clamp was similarly touted as a life saving
device. This is basically a big clamp with large pins that go through the skin,
into the pelvic bones, and the device squeezes the two halves of the broken pelvis
together. The principle is similar to a pelvic external fixator or a blinder,
but it had theoretical advantages. Like pelvic packing (below) there were
reports of it being effective, but no good comparative studies were performed.
The only studies are small case series with mortality rates of about 25-35%, which doesn’t
fill me with confidence that this device is a life saver. Also, the C clamp has
been associated with some pretty nasty complications, like driving the pins
through the pelvis into the internal organs and dislocating the pelvis.
Packing the pelvis
In a before-and-after study of pelvic packing versus initial
angiography (here),
there was no significant difference in mortality. In a similar study (here), they concluded
that packing was better than angiography, but when you are comparing 40%
mortality to 60% mortality with 10 patients in each group, it is hard to make
any firm conclusions.
Pelvic packing is still associated with a high mortality,
and there have been no good comparative studies, so it gets relegated to the
“at least we are trying something” group – a group with a bad track record. This 2009 review doesn’t
offer any comparative studies.
And when authors use the term “paradigm shift” in the title
(here) to talk about
the treatment, and then go on to describe a 25% mortality rate and conclude
that the treatment is effective, without any control group, it is time to look
skeptically at that particular treatment.
Angiographic embolization
(AE)
I know what you are thinking: “All those things don’t matter
any more, because we now embolize all the bleeding arteries via percutaneous
angiographic techniques”. That is why I saved this one until last. Nothing, except maybe a tourniquet (applied correctly, to an appropriate injury, of
course) stops bleeding like embolization. I mean, you see this artery bleeding
on the screen and then Bam! You just blocked it off. How can I argue my way out
of this one? Firstly, consider that embolization only blocks arteries, not veins (which also bleed, a lot);
that it simply diverts blood to other areas that may also be bleeding; and that
the arteries don’t always stay blocked for very long.
Studies like this
one simply show how effective AE is in stopping bleeding, but nothing about
its effect on mortality. Are there any controlled studies? Not really. There is
a before-and-after study
that shows that it might be worse than pelvic packing, but not much else.
This
review of pelvic trauma in Germany over two decades did not show much
change in mortality, despite all the changes in practice referred to above.
The bottom line
If I am treating a patient bleeding in front of me, will
I stop the bleeding? Yes, if I can do it without adding to the bleeding or
increasing the risk. And apart from stopping the bleeding, I will replace the
blood and plasma that he has lost. However, it is likely that the treatments we used
to provide (high volume infusions, colloid infusions, pre-hospital care,
splenectomy, pelvic external fixation, MAST suits, etc.) probably never worked
in the first place, despite our beliefs and the ‘evidence’ at the time. And
much of the stuff we do now (pelvic packing, angiography, tourniquets, etc.) is
based on a similar level of evidence.
If we can question our interventions to stop bleeding in
trauma patients, which is probably the best biological mechanism I have ever
heard, then what other accepted, seemingly obvious medical treatments should we also be
questioning?
Thanks for a great article Dr Skeptic, but it actually leaves me with more questions than answers, the most important of which is: faced with the clinical scenario of a haemodynamically unstable patient with a pelvic fracture (and no other sources of bleeding) - what should I do, based on the current evidence?
ReplyDeleteThanks Abhinav,
DeleteFirstly, don't ever assume that you have to do something, that is what gets us into so much trouble: not accepting that doing nothing is sometimes better than doing something.
Secondly, do no harm. Temporary binding with a sheet might not have any good evidence, but it probably does little harm. At the other end of the spectrum, open surgery to pack the pelvis or ligate bleeders has significant risks without good supporting evidence.
Thirdly, use the evidence. The lack of RCTs doesn't mean there is no evidence, it means we have to use other evidence, even to the point where we have to rely on expert opinion. I feel that expert opinion in this field is biased towards intervention (for all the reasons mentioned throughout this blog), but even the experts will accept that to some degree.