Evaluation of coagulation factor concentrates for persistent bleeding after cardiothoracic surgery

The purpose of this study was to evaluate the effectiveness and safety of changes to a protocol for refractory bleeding after cardiothoracic surgery. The protocol changes included adjusting from a weight-based to a fixed-dosing strategy for 4-factor prothrombin complex concentrate (4F-PCC) and decreasing the weight-based dosing of recombinant activated factor VII (rFVIIa).

This was a pre-post retrospective cohort study evaluating 198 adult patients after cardiothoracic surgery requiring cardiopulmonary bypass at an academic medical center between May 2019 to October 2021 (before protocol change) and November 2021 to September 2022 (after protocol change). The primary outcome was chest tube output at 24 hours after the operation in patients who received at least one dose of 4F-PCC or rFVIIa. Secondary endpoints included transfusion volume, the rate of re-exploration events, length of stay, and 30-day mortality.

The primary outcome of chest tube output at 24 hours was 720 mL in the pre-change group and 700 mL in the post-change group (P = 0.982). The volume of fresh frozen plasma (FFP) transfusions significantly decreased from a median of 4 units to 2 units (P < 0.001). The median dose of 4F-PCC in the pre- vs post-change group was 24.6 vs 26.3 units/kg (P = 0.011), while that of rFVIIa was 59.5 vs 24.5 μg/kg (P = 0.000). The other secondary and safety outcomes were similar between the groups. The average cost savings was $3,585.45 per patient.

Patients in the post-change group had similar chest tube output, re-exploration rates, and incidence of thrombotic events. The post-change group received significantly less FFP and less coagulation factor concentrate while maintaining hemostasis and reducing cost.