Novel Oral Anticoagulants in Trauma and Surgery Guideline
VBMC TRAUMA CARE SERVICES GUIDELINE
Novel Oral Anticoagulants in Trauma and Surgery Guideline
Introduction
Coagulopathy, either drug related or multifactorial,
is a major contributing factor to bleeding related mortality in a variety of clinical
settings. Standard therapy for control of coagulopathy related bleeding has
traditionally been limited to the utilization of available blood products,
reversal of drug-induced anticoagulation, and recombinant activated factor VII
(rFVIIa). With the implementation of the difficult to reverse new oral
anticoagulants, dabigatran (Pradaxa®), apixaban (Eliquis®)
and rivaroxaban (Xarelto®), the need for a standardized reversal
protocol is warranted. Praxbind is now approved for reversal of dabigatran but
should be used only if dabigatran use is specifically confirmed.
The following guideline to standardize the utilization, dosing, monitoring, and dispensing of agents used in traumatic, life-threatening, or drug induced coagulopathies.
Indication to Use the Guideline
Obtain history of possible oral
anticoagulant use from patient, family, EMS, or referring facility when
possible. If history is unknown, consider the possibility of their use in
patient based on their known past medical history (i.e. history of atrial fibrillation
or deep venous thrombosis). This protocol is intended to be used for bleeding
in the case of:
·
Anticoagulant use (see below)
·
Antiplatelet use (see below)
·
Trauma
·
Intracranial hemorrhage
·
Stroke
·
Emergency surgery
Process
The following labs should be
drawn STAT and repeated as clinically indicated. While these
labs may help to identify the presence or absence of oral anticoagulants the
results of these studies should not delay the anticoagulation reversal
treatment if a history of oral anticoagulant use is present or known.
1.
CBC
2.
PT/INR
3.
BMP
4.
aPTT
5.
TT (thrombin time)
Anticoagulant Reversal Agents
If a drug-induced coagulopathy is
suspected and reversal is indicated, activated prothrombin complex concentrate
(aPCC), 4 factor prothrombin complex concentrate (4PCC) or rFVIIa can be used.
For unknown ingestion of the newer agents, Dabigatran, apixaban, and
rivaroxaban, more complete reversal has been seen with the use of aPCC’s when
compared to PCC’s. Dabigitran reversal is now possible with Praxbind (above).
The aPCC on formulary is FEIBA (factor eight inhibitor bypassing
activity) while the 4 factor PCC product is Kcentra.
If any of these therapies are
warranted, please contact the pharmD on call for indication, dosing, and
administration assistance.
|
Comparison of aPCC and rFVIIa Products |
|||
|
Activated PCC |
4PCC |
rFVIIa |
|
|
Brand Name |
Feiba® |
Kcentra® |
NovoSeven® |
|
Factors Provided |
II,
IX, X, VIIa |
II,
IX, X, VII |
VIIa |
|
Activated |
Yes |
No |
Yes |
|
Drug
Induced Coagulopathy Reversal |
|||
|
Warfarin |
Yes |
Yes |
Yes |
|
Dabigatran |
Yes |
No |
No€ |
|
Rivaroxaban |
Yes |
Yes |
No€ |
|
Apixaban |
NA£ |
NA£ |
NA£ |
€ literature is divided between in vitro and clinical studies
£ newest agent with smallest amount of data, initial reports put its
reversal similar to Rivaroxaban the other
Factor Xa
inhibitor
* may repeat dosing up to 3 times if clinically indicated
Procedure for Ordering and Dispensing
When a patient presents with bleeding
and it is determined by the attending physician that the patient would benefit
from either rFVII or FEIBA a page/call to the PharmD on call will be
placed.
· This
will alert the pharmD to come and assess the patient for their potential risk,
assist with laboratory interpretation and help to decide the appropriateness of
reversal.
· PharmD
will discuss with appropriate physician the appropriateness and which reversal
agent would be indicated in this particular patient.
If the decision is made to give a
particular reversal agent, the pharmD will further assist by bringing the drug
to the patient bedside, prepare the dose for administration, while also
prompting discussions on potential alternative/adjunctive therapies that might
impact the efficacy of the agent selected.
Non-Drug Induced Coagulopathy
Reversal
Not all coagulopathies will be drug induced. After the optimization of
supportive care measures have been done and drug induced causes have been ruled
out it is appropriate to follow previously established protocols (i.e. massive
transfusion protocol).
Antiplatelet Reversal
If ingestion of one of the following
oral antiplatelet agents is present during coagulopathy consider platelet
transfusion. Consider using TEG to assess clot formation, realizing that the
reagents used in TEG can overcome the effect of platelet dysfunction in vitro
and show a 'falsely normal' TEG.
· Clopidogrel
(Plavix®)
· Ticagrelor
(Brilinta®)
· Prasugrel (Effient®)
· Ticlopidine
(Ticlid®)
Heparin-Induced
Thrombocytopenia
Heparin is one of the most commonly administered
therapeutic agents in hospitals. Each year, approximately 12 million
patients—or one third of all hospitalized patients—are exposed to heparin.
Heparin-induced thrombocytopenia (HIT), which may cause morbidity and
mortality, develops in approximately 1% to 5% (up to 600,000 patients). HIT may
be under-recognized and under-diagnosed. Consequences of HIT include
venous or arterial thrombosis and, rarely, bleeding. In patients with acute
thrombosis, HIT can be fatal. Treatment of HIT includes discontinuation of
heparin therapy and the use of parenteral non-heparin anticoagulants such as
direct thrombin inhibitors.