Factor XIII Concentrate Mitigates Hemorrhage in Pediatric Extracorporeal Membrane Oxygenation Support With Acquired Factor XIII Deficiency.

Bleeding is a major complication in patients on extracorporeal membrane oxygenation (ECMO). Acquired factor XIII (FXIII) deficiency develops during ECMO support; however, little is known about the effects of FXIII administration on bleeding ECMO outcomes. Our study aimed to evaluate the effect of FXIII concentrate on bleeding during ECMO and suggest an FXIII threshold level. Retrospective review of pediatric ECMO patients who received FXIII infusion. The International Society on Thrombosis and Hemostasis (ISTH) bleeding definition was used to classify bleeding as none (0), minor (1), clinically relevant non-major (2), and major (3). Factor XIII levels and bleeding scores were compared pre- and post-FXIII concentrate. Twenty patients received 27 infusions of FXIII. Factor XIII concentrate dosing was 37 ± 8 units/kg. Factor XIII levels increased from 41% (interquartile range [IQR]: 37-46) to 68% (IQR: 57-82), p value of less than 0.001. Bleeding severity improved after FXIII infusion; the mean ISTH bleeding score decreased from 2.0 ± 0.7 to 0.8 ± 0.9, p value of less than 0.001. Sixteen patients were successfully off ECMO and survived to discharge. Factor XIII administration was associated with improvement in bleeding severity when the initial FXIII level value was less than 50%. Pediatric ECMO patients with persistent bleeding should have FXIII levels measured and consideration of FXIII administration should be made at FXIII level value of less than 50%.