Reversal of Direct Oral Anticoagulants (DOAC) Direct Thrombin Inhibitors (i.e.Dabigatran)   Due to the availability and licensure of a specific antidote (Idarucizumab ) for the Direct Thrombin Inhibitor, Dabigatran, in Canada, the use of prothrombin complex concentrates, FEIBA or recombinant Factor VIIa in the reversal of this agent is not recommended .

Reversal of Direct Oral Anticoagulants (DOAC) Direct Factor Xa Inhibitors (i.e.Rivaroxaban or Apixaban).   Although animal, human volunteer and small retrospective observational studies have been published using plasma protein products for reversal of Direct Oral Anticoagulants, at this time there are still no good quality controlled studies in humans using clinical bleeding outcomes as an endpoint that has evaluated these as reversal agents. With this lack of evidence for dosing, safety and efficacy of these products the National Advisory Committee on Blood and Blood Products (NAC) cannot develop a recommendation for use of prothrombin complex concentrates, FEIBA or recombinant Factor VIIa in the reversal of Direct Factor Xa Inhibitors. The administration of Frozen plasma or Vitamin K will not be of any benefit in the setting of DOAC associated bleeding unless concomitant coagulopathy of a different etiology is present.

Reversal of Direct Oral Anticoagulants (DOAC) However, it is important to ensure that the following steps are considered in patients who present with moderate or major bleeding while on a Direct Factor Xa Inhibitors until a specific antidote becomes available:   Consult with Hematology/Thrombosis and/or Transfusion Medicine Physician. Hold the anticoagulant. Hold any concomitant anti-platelet drugs. Transfusion of platelets may be appropriate if major bleeding and history of anti-platelet use. Investigate and treat source of bleeding. Utilize local therapy /site control as appropriate. Transfuse red cells as appropriate. If adequate renal function – delay surgical / interventional procedures until drug has cleared if possible. Consider use of Tranexamic acid (No studies are available for dosing or efficacy but possible doses could be 1 gram or 10 mg/kg IV). Institutional protocols for management of life or limb threatening bleeds due to Factor Xa inhibitors should be developed and implemented. Protocols should include relevant laboratory testing and hemostatic management. Additional information from Thrombosis Canada is available at www.thrombosiscanada.ca