Blood clotting promoter:
FDA APPROVES GEL TO STOP
BLOOD FLOW DURING BLOOD
In October 2011 the U.S. Food and
Drug Administration has approved
LeGoo, a gel that allows surgeons to
temporarily stop blood flow during
surgery so that they can join blood
vessels without clamps or elastic loops.
LeGoo is manufactured by PluroMed
Inc. of Woburn, Mass.
To join blood vessels during surgery, it
is necessary to temporarily stop blood
flow to the area where a new vessel is
being attached. Stopping blood flow
prevents flooding the surgical area
with blood, which makes it difficult for
the surgeon to clearly see where to
place sutures to connect the two
LeGoo has been shown to minimize
blood flow into the surgical area
without damaging blood vessels.
Standard tools, such as elastic loops
and clamps, do not always allow for a
bloodless surgical area and may
LeGoo is a temperature sensitive gel
that is liquid at room temperature and
solid at higher temperatures. When
injected into a blood vessel, LeGoo
forms a gel plug that molds to the
shape of the blood vessel and stops
blood flow for up to 15 minutes.
After the blood vessels are joined, the
plug is expected to dissolve on its own
in 15 minutes.
The FDA looked at data from a clinical
trial of 110 patients undergoing bypass
surgery without stopping the heart (off
pump coronary artery bypass).
Investigators found that LeGoo is as
safe and effective as vessel loops,
devices commonly used to stop blood
flow during coronary bypass surgery.
TXA, AN INEXPENSIVE DRUG FOR
If recently injured patients with serious
bleeding were to receive a cheap,
widely available and easily
administered drug to help their blood
to clot, tens of thousands of lives could
be saved every year, according to a
paper published on-line by The Lancet.
TXA (tranexamic acid) is an off-patent
drug, manufactured by a number of
different companies. The cost per
gram is about $4.50.
A trial, named CRASH-2, was a large,
randomised trial involving over 20,000
adult patients in 274 hospitals across
40 countries, and was funded by
England's National Institute for Health
Research (NIHR) Health Technology
Assessment program. This is the first
trial of TXA in injured patients,
although smaller trials have shown that
it reduces bleeding in patients
undergoing major surgery.
The drug helps by reducing clot
breakdown. Although this would be
advantageous in patients with severe
bleeding, doctors were worried that
TXA might increase the risk of
complications, such as heart attacks,
strokes and clots in the lungs. The
results of this large trial show that TXA
reduces death from bleeding without
any increase in these complications.
Severely injured adults were enrolled
in the trial if they had significant
bleeding, or were at risk of significant
bleeding and were within a few hours
of injury. They were randomly
allocated to receive either one gram of
TXA by injection, followed by another
one gram in a drip over the following
eight hours, or a matching placebo.
The researchers studied the numbers
of deaths in hospital within four weeks
of injury in the two groups and found
that TXA reduced the chances of
death due to massive blood loss by
about one sixth.
The researchers estimate that
administering TXA soon after injury
could prevent up to 100,000 deaths
per year across the world.
Thrombin-JMI by King Pharma, is used
to stop bleeding during surgeries;
blood-clotting drug, Recothrom;
Johnson & Johnson also has a