Comparison of the Coagulation Profile Following Treatment of Major Surgical Haemorrhage with Fresh Frozen Plasma or Fibrinogen Concentrate.

Abstract

In a parallel-assignment, single-blinded study, we measured the detailed coagulation profile of 20 patients randomized to receive infusions of fresh frozen plasma (FFP) or fibrinogen concentrate during surgery associated with major surgical hemorrhage-Extent 4 Thoraco-abdominal Aortic Aneurysm repair. Ten patients received FFP; 10 fibrinogen concentrate, infused to achieve plasma fibrinogen concentration around 1.5 g/L. There were predefined hemoglobin and ROTEM cut-offs for red cell and platelet administration. Blood samples were taken at up to 12 predefined time points before, during, and after surgery. Measurements included coagulation and anticoagulant factor concentrations, thrombin generation, activated protein C (aPC) concentrations, and thromboelastography. Intraoperative blood loss was between 2,750 and 16,500 mL. During surgery, plasma fibrinogen concentration was slightly lower in the FFP group but maintained or restored to approximately 1.5 g/L. When blood loss exceeded approximately 4,000 mL, most factor concentrations and conventional tests were superior in the FFP group. Mean (standard deviation) prothrombin time (15.8 [2.3] vs. 26.3 [5.1]) and activated partial thromboplastin time (42.8 [8.6] vs. 60.4 [15.8]) seconds; p < 0.001. Protein C and aPC concentrations trended higher in the FFP group: protein C = 59.7 (18.4) versus 30.0 (10.6)% normal; p < 0.001, aPC = 6.9 (5.5) versus 3.1 (2.3) g/L; p = 0.001. Differences in peak thrombin generation 2 hours postoperatively in the FFP group did not meet statistical significance: (224.3 [54.8] vs. 133.0 [66.0]) nM; p = 0.004. In this exploratory cohort, both FFP and fibrinogen concentrate administration achieved low-normal plasma fibrinogen concentrations. Although coagulation factor concentrations and thrombin generation were lower in the fibrinogen concentrate group at blood losses above 4,000 mL, this was not associated with worse surgical hemostasis or observed bleeding complications. · Question: in patients undergoing major surgical hemorrhage during thoracoabdominal aortic aneurysm repair, how does treatment with FFP compare with fibrinogen concentrate in maintaining coagulation profiles?. · Findings: both treatments maintained plasma fibrinogen concentrations, but patients receiving FFP had higher levels of coagulation factors, thrombin generation, and aPC when blood loss exceeded 4,000 mL.. · Meaning: although FFP led to superior laboratory coagulation parameters at high blood loss, in this exploratory cohort with blood losses of up to 16,500 mL, observed hemostasis remained clinically satisfactory when managed by either fibrinogen concentrate or FFP..