Critical Bleeding Reversal Protocol

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1 Critical Bleeding Reversal Protocol 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 within UKHealthCare is warranted. UKHealthcare has developed the following guideline to standardize the utilization, dosing, monitoring, and dispensing of agents used in traumatic, life-threatening, or drug induced coagulopathies. Indication 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) Intracranial hemorrhage Antiplatelet use (see below) Emergent surgery Trauma Stroke Laboratory Evaluation 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. CBC PT/INR BMP aptt TT

2 Critical Bleeding Management Protocol Bleeding Reversal Treatment Protocol 2

3 Anticoagulant Reversal Agents Indication Drug Dose Max Dose Known Drug Exposure Direct Thrombin s Dabigatran (Pradaxa ) Bivalirudin Argatroban Factor Xa s Rivaroxaban (Xarelto ) Apixaban (Eliquis ) Fondaparinux Vitamin K Antagonist FEIBA (apcc) Kcentra (4PCC) units/kg 25 units/kg 100 units/kg 2500 units/kg INR Dose INR Dose Warfarin (Coumadin ) Kcentra (4PCC) units/kg units/kg units/kg units/kg > 6 50 units/kg > units/kg Anticoagulant Exposure Suspected Specific agent unknown FEIBA (apcc) units/kg 100 units/kg No Anticoagulant Exposure Suspected No Cause for Drug Contribution rfviia 30 mcg/kg 90 mcg/kg assuming FFP/vitamin K have already been administered Reversal Agent Review If a drug-induced coagulopathy is suspected and reversal is indicated activated prothrombin complex concentrate (apcc) or rfviia can be used. For the newer agents, Dabigatran, apixaban, and rivaroxaban, more complete reversal has been seen with the use of apcc s when compared to PCC s. The UKHealthcare apcc on formulary is FEIBA (factor eight inhibitor bypassing activity). While apcc s have also been shown to reverse Warfarin, at this time the literature does not support its use over the current treatments of choice (FFP, and rfviia). The risk of thrombotic events with FEIBA when compared to rfviia has not been shown to be superior in the reversal of INR. If any of these therapies are warranted please contact the pharmd on call for indication, dosing, and administration assistance (pager # 7400). 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 No No Apixaban NA No NA 3

4 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 Agent Review and Coagulation Evaluation Drug Dabigatran (Pradaxa ) Rivaroxaban (Xarelto ) Apixaban (Eliquis ) Warfarin (Coumadin ) Mechanism of Action Direct Thrombin Factor Xa Factor Xa Vitamin K Antagonist Half Life PT/INR aptt hours 5-19 hours 9-14 hours INR reversal 6-24 hours w/ vit K 7-24 hours w/ FFP Minutes w/ FEIBA Not elevated at therapeutic levels, mod elevated at supra-therapeutic levels Elevated levels consistent with ingestion at higher doses Elevated levels consistent with ingestion at higher doses Elevation in relation to dose Elevation indicative of presence but not degree of anticoagulation 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 4

5 If ingestion of one of the following oral antiplatelet agents is present during coagulopathy consider platelet transfusion. Clopidogrel (Plavix ) Ticagrelor (Brilinta ) Prasugrel (Effient ) Ticlopidine (Ticlid ) 5

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