Prophylactic Recombinant Factor VIIa for Preventing Massive Transfusion During Orthotopic Liver Transplantation.

OBJECTIVES: RecombinanthumanactivatedfactorVIIahas been usedprophylactically to mitigate requirements for transfusion in liver transplant. We explored its effectiveness andrisks amonglivertransplantrecipients at high risk for massive transfusion. MATERIALS AND METHODS: We performed a retrospective study of recipients who underwent liver transplant from 2012 to 2015. Patients considered at risk for massive transfusion received up to two 20 µg/kg doses of recombinant human activated factor VIIa, with rescue use permitted for other patients. We used propensity matching to determine the average treatment effectson patients who received recombinant human activated factor VIIa prophylactically to prevent massive transfusion. We determined thromboembolic events from medical record review. RESULTS: Of 234 liver transplant recipients, 38 received prophylactic and 2 received rescue recombinant human activated factor VIIa. We used a prediction model to readily identify those who would receive prophylactic recombinant human activated factorVIIa (C statistic = 0.885; 95% CI, 0.835-0.935). Propensity matching achieved balance, particularly for massive transfusion. Twenty-three of 38 patients (60.5%) who received recombinant human activated factorVIIa and 47 of 76 matched controls (61.8%) experienced massive transfusion. The coefficient for the average treatment effect of prophylactic administration was - 0.013 (95% CI, -0.260 to 0.233; P = .92). The cohorts exhibited no difference in number ofthromboembolic events (P > .99), although fatal events occurred in 1 patient who had prophylactic and 1 patient who had rescue recombinant human activated factor VIIa. CONCLUSIONS: Prophylactic recombinanthumanactivated factor VIIa use in patients at elevated risk of massive transfusion did not affect incidence of massive transfusion and was not associated with an increase in thromboembolic events overall. The lack of clinical benefit and the potential for fatal throm-boembolic events observed with recombinant human activated factor VIIa precluded its prophylactic use in liver transplant recipients.

Validation of predictive models identifying patients at risk for massive transfusion during liver transplantation and their potential impact on blood bank resource utilization.

BACKGROUND: Intraoperative massive transfusion (MT) is common during liver transplantation (LT). A predictive model of MT has the potential to improve use of blood bank resources. STUDY DESIGN AND METHODS: Development and validation cohorts were identified among deceased-donor LT recipients from 2010 to 2016. A multivariable model of MT generated from the development cohort was validated with the validation cohort and refined using both cohorts. The combined cohort also validated the previously reported McCluskey risk index (McRI). A simple modified risk index (ModRI) was then created from the combined cohort. Finally, a method to translate model predictions to a population-specific blood allocation strategy was described and demonstrated for the study population. RESULTS: Of the 403 patients, 60 (29.6%) in the development and 51 (25.5%) in the validation cohort met the definition for MT. The ModRI, derived from variables incorporated into multivariable model, ranged from 0 to 5, where 1 point each was assigned for hemoglobin level of less than 10 g/dL, platelet count of less than 100 × 109 /dL, thromboelastography R interval of more than 6 minutes, simultaneous liver and kidney transplant and retransplantation, and a ModRI of more than 2 defined recipients at risk for MT. The multivariable model, McRI, and ModRI demonstrated good discrimination (c statistic [95% CI], 0.77 [0.70-0.84]; 0.69 [0.62-0.76]; and 0.72 [0.65-0.79], respectively, after correction for optimism). For blood allocation of 6 or 15 units of red blood cells (RBCs) based on risk of MT, the ModRI would prevent unnecessary crossmatching of 300 units of RBCs/100 transplants. CONCLUSIONS: Risk indices of MT in LT can be effective for risk stratification and reducing unnecessary blood bank resource utilization.