Case report: A patient with hemophilia was receiving both
intravenous coagulation factors for his hemophilia and topical
human recombinant thrombin (Recothrom) to treat surgical wound
oozing. The nurse took both coagulation factor and Recothrom into
the patient’s room. After being interrupted by other urgent care
needs, the nurse picked up the Recothrom and administered it
intravenously. The patient coded but was successfully
resuscitated since the nurse quickly recognized and openly
acknowledged his error, enabling the code team to provide
appropriate timely treatment.
Thrombin, a component in the coagulation cascade, can be used for
topical hemostasis or to treat pseudoaneurysms by direct
injection. It has long been known that inadvertent intravenous
injection can be rapidly fatal (e.g., rabbits died within 30
seconds of injection).(Wesley & Wesley, 1990) Wesley & Wesley
recommended coloring the solution with methylene blue to reduce
the risk of error. In 2008, the Institute for Safe Medication
Practices (ISMP) issued an alert highlighting the danger of
giving topical thrombin intravascularly.(ISMP, 2008)
Most thrombin formulations currently available avoid including a
Luer syringe in the reconstitution kit to minimize the risk of
mistaking the final product for an IV-safe medication. Recothrom,
a recombinant human thrombin preparation, does not. Instead, it
includes a label in the kit that is to be affixed to the Luer-tip
syringe prior to drawing up the final product. The combination of
an easily-forgotten extra step (attaching the label) and an
error-prone connector increases the risk of administration error.
A search of the CHPSO database found other errors associated with
thrombin and IV syringes. For example:
During surgery, after a personnel change an unlabeled syringe
of Recothrom was confused with lidocaine and infiltrated into the
During surgery, an unlabeled medicine cup of thrombin was
mixed with local anesthetic and injected into the wound.
During surgery, steroid injection and Recothrom were drawn up
in syringes and passed to the surgeon mixed together. The error
was noticed prior to injecting the medications.
During surgery, “heparin” on the table was actually thrombin.
The error was discovered prior to use.
A nurse reconstituted Recothrom thinking it was Factor VIII
and was about to give it. Fortunately, the pharmacy tech at that
same time was delivering the syringe of Factor VIII to the nurse.
It turns out the Recothrom was for control of a bleeding IV site.
A medication cart in the cardiothoracic operating room was
supplied with thrombin (Recothrom) instead of antithrombin III,
due to the similarity of the names. The error was discovered when
the anesthesiologist was preparing the patient for
cardiopulmonary bypass and pulled what she thought was
antithrombin III out of the cart.
A radiologist asked a nurse to pick up human thrombin
(Recothrom) from the pharmacy. The nurse returned with a syringe
of antithrombin III, which was injected into a pseudoaneurysm.
After no response to the injection, the error was identified and
the patient successfully treated with a syringe of Recothrom.
Investigation showed multiple episodes of confusion between
“human thrombin” and “human antithrombin” (nurse, pharmacist, and
radiologist) as one cause of the error.
Since Recothrom is the only available human recombinant thrombin,
it may be necessary to continue its use in many settings, as the
other available forms of thrombin (bovine, human-pooled plasma)
have their own drawbacks.(Lomax, 2009) The warnings from the ISMP
alert are still relevant, along with a continuing scrutiny of
surgical use, as that is a particularly common site for topical
thrombin use along with a common source of reported events. The
following is a summary of the ISMP warnings:
Whenever possible, have the pharmacy dispense the
reconstituted drug with appropriate labels, including doses used
in the operating room.
Never leave thrombin at the patient’s bedside as it can later
be confused as a parenteral product.
Apply warning labels to the product.
Communicate the presence of topical thrombin when placing on
the sterile field and try to delay placing it there until all
parenteral products have been administered.
Consider using spray kits for topical thrombin.
Differentiate parenteral and topical products, such as using
the topical thrombin in powder form or adding it to an absorbable
Additional recommendations from CHPSO:
Avoid placing topical products in Luer-tip syringes. For
example, unless the order was for use in a pseudoaneurysm, the
pharmacy could transfer the Recothrom from the kit’s Luer-tip
syringe into an oral-tip syringe.
Always label medications and solutions in the operating room,
both on and off the sterile field. Note that this is already a
Joint Commission standard.
The terms “human thrombin” and “human antithrombin” are
readily confused. Take measures to strongly differentiate the
two, such as tall-man labeling (ANTIthrombin).