Transfusion and hematologic variables after fibrinogen or platelet transfusion in valve replacement surgery: preliminary data of purified lyophilized human fibrinogen concentrate versus conventional transfusion

• Published in: Transfusion (Philadelphia, Pa.) Pa.), 2014-01, Vol.54 (1), p.109-118
• Main Authors: Tanaka, Kenichi A., Egan, Katherine, Szlam, Fania, Ogawa, Satoru, Roback, John D., Sreeram, Gautam, Guyton, Robert A., Chen, Edward P.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Blood. Blood and plasma substitutes. Blood products. Blood cells. Blood typing. Plasmapheresis. Apheresis; Cardiac Valve Annuloplasty - adverse effects; Coagulants - administration & dosage; Coagulants - adverse effects; Female; Fibrinogen - administration & dosage; Fibrinogen - adverse effects; Freeze Drying; Humans; Length of Stay - statistics & numerical data; Male; Medical research; Medical sciences; Middle Aged; Platelet Transfusion - adverse effects; Platelet Transfusion - methods; Postoperative Hemorrhage - epidemiology; Postoperative Hemorrhage - etiology; Postoperative Hemorrhage - therapy; Transfusions. Complications. Transfusion reactions. Cell and gene therapy
• ISSN: 0041-1132; 1537-2995
• DOI: 10.1111/trf.12248

Background Platelet (PLT) and plasma transfusion remain the mainstay hemostatic therapy for perioperative bleeding. Several studies have indicated that acquired fibrinogen (FIB) deficiency can be the primary cause of bleeding after cardiac surgery. The aim of this study was to compare hematologic and transfusion profiles between the first‐line FIB replacement and PLT transfusion in post–cardiac surgical bleeding. Study Design and Methods In this prospective, randomized, open‐label study, 20 adult patients who underwent valve replacement or repair and fulfilled preset visual bleeding scale were randomized to 4 g of FIB or 1 unit of apheresis PLTs. Primary endpoints included hemostatic condition in the surgical field and 24‐hour hemostatic product usage. Hematologic data, clinical outcome, and safety data were collected up to the 28th day postoperative visit. Results In patients who received the first‐line FIB concentrate (n = 10), the visual bleeding scale improved after intervention, and the incidence of PLT transfusion and total plasma donor exposure were lower compared to the PLT group (n = 10). Postintervention FIB level was statistically higher (209 mg/dL vs. 165 mg/dL) in the FIB group than in the PLT group, but PLT count and prothrombin were lower. There were no statistical differences in the postoperative blood loss and red blood cell transfusion between two groups. Conclusions Our preliminary data indicate that the primary FIB replacement may potentially reduce the incidence of PLT transfusion and the number of donor exposures. Plasma FIB level of 200 mg/dL is attainable with a single dose of 4 g, and this level seems to mitigate bleeding despite moderately decreased thrombin generation.