title: Small-dose recombinant activated factor VII (NovoSeven) in cardiac surgery.
abstract: Recombinant activated factor VII (rFVIIa) has been used at different doses in cardiac surgery patients. We tested the efficacy of small-dose rFVIIa in patients with intractable bleeding after cardiac surgery. The study group comprised 15 cardiac surgery patients with intractable bleeding treated with small-dose (1.2 mg) rFVIIa as a slow IV bolus at the end of complete step-by step transfusion protocol. Fifteen matched patients undergoing the same transfusion protocol in the pre-rFVIIa era represented the control group. Blood loss at the end of the transfusion protocol was a primary outcome. Median, 25th-75th 24-h blood loss percentiles were 1685 (1590-1770) mL versus 3170 (2700-3850) mL in study group and controls, respectively (P = 0.0004). Transfused red blood cells, fresh-frozen plasma, and platelets in the study group and controls were as follows: 7 (4-8) U versus 18 (12-21) U (P = 0.001); 7.5 (6-11) U versus 11 (9-15) U (P = 0.003); 0 (0-4) U versus 9 (6-13) U (P = 0.001). In addition, significant improvements of prothrombin time (P = 0.015), international normalized ratio (P = 0.006), activated partial prothrombin time (P = 0.01), and platelet count (P = 0.003) were detected in the study group versus controls. Finally, patients receiving rFVIIa showed a reduced intensive care unit length of stay (chi2 = 15.9, P = 0.0001) and had infrequent surgical re-exploration (chi2 = 16.2,P < 0.0001). Small-dose rFVIIa showed satisfactory results in cardiac patients with intractable bleeding. Further randomized studies are necessary to confirm our findings.
authors.affiliation: Department of Cardiac Surgery; Careggi Hospital, Florence, Italy. romagnoliste@tiscali.it
authors.forename: Stefano
authors.initials: S
authors.lastname: Romagnoli
authors.forename: Sergio
authors.initials: S
authors.lastname: Bevilacqua
authors.forename: Sandro
authors.initials: S
authors.lastname: Gelsomino
authors.forename: Silvia
authors.initials: S
authors.lastname: Pradella
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Ghilli
authors.forename: Carlo
authors.initials: C
authors.lastname: Rostagno
authors.forename: Gian Franco
authors.initials: GF
authors.lastname: Gensini
authors.forename: Carlo
authors.initials: C
authors.lastname: Sorbara
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D016009:Chi-Square Distribution; D015942:Factor VIIa / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000188:drug therapy*; D011517:Prothrombin Time / Q000706:statistics & numerical data; D018709:Statistics, Nonparametric
chemical_list: D015942:Factor VIIa