Because a suitable comparator group was not available, the panel was unable to judge the benefits of administration of coagulation factor Xa (recombinant), inactivated-zhzo on outcomes associated with life-threatening bleeding during direct Xa inhibitor therapy. Harms and burden. Because a suitable comparator group was not available, the panel was unable to judge the harms and burdens of administration of coagulation factor Xa (recombinant), 27 NOVEMBER 2018 x VOLUME 2, NUMBER 22 ASH 2018 VTE GUIDELINES: ANTICOAGULATION MANAGEMENT 3279 inactivated-zhzo on outcomes associated with life-threatening bleeding during direct Xa inhibitor therapy. Other EtD criteria and considerations. Costs of coagula- tion factor Xa (recombinant), inactivated-zhzo are extremely high (estimated at $27 500 to $50 000 for the bolus dose in the United States). Access to coagulation factor Xa (recombinant), inactivated-zhzo is also uncertain, due to issues pertaining to the manufacturing process. Administration of coagulation factor Xa (recombinant), inactivated-zhzo in the setting of life-threatening bleeding is likely to be somewhat complicated but is probably feasible in the hospital setting. Conclusions and research needs for this recommendation. Based on the absence of data for the comparator, very low certainty evidence from 1 observational study, and the extremely high cost of the intervention, the panel could not come to a unanimous decision. Voting resulted in a conditional recommendation for administration of coagulation factor Xa (recombinant), inactivated-zhzo, primarily based on the evidence for direct Xa inhibitor reversal and biological plausibility of preventing worsening of bleeding for widely used anticoagulants, the direct Xa inhibitors, using a specific reversal agent. Whether coagulation factor Xa (recombinant), inactivated- zhzo is associated with excess thromboembolism is unknown. This recommendation does not apply to non life-threatening bleeding, because the cost likely outweighs potential benefit. The panel identified the following additional research questions. 