title: Change of coagulation after NovoSeven® use for bleeding during cardiac surgery.
abstract: Objectives Recombinant activated factor VII has been used for the treatment of hemophilia, factor VII deficiency, and Glanzmann's thrombasthenia. Off-label uses have recently been increasing, and there are reports that recombinant activated factor VII is effective for the treatment of excessive bleeding during or after cardiovascular surgery. We retrospectively reviewed the effectiveness of recombinant activated factor VII and its influence on the coagulation system as a treatment for uncontrollable bleeding during cardiovascular surgery. Methods Between April 2009 and May 2015, recombinant activated factor VII was used to treat uncontrollable bleeding during cardiovascular surgery in 17 patients at our hospital. The indications for recombinant activated factor VII administration were critical uncontrollable bleeding during surgery and normal platelet and fibrinogen levels. Results Blood loss significantly decreased in every case after recombinant activated factor VII administration ( p < 0.05). No adverse thromboembolic events were encountered. The prothrombin time-international normalized ratio, activated partial thromboplastin time, fibrin degradation product and D-dimer levels decreased significantly after recombinant activated factor VII administration. One day later, all blood coagulation test values were almost within the normal ranges. Conclusions Recombinant activated factor VII has a strong hemostatic action, but it is necessary to exclude surgical bleeding to exhibit the hemostatic effect. Administration that does not comply with the indications for recombinant activated factor VII may lead to serious complications such as thromboembolism. In properly selected patients, recombinant activated factor VII is an effective agent for the treatment of uncontrollable bleeding during cardiovascular surgery.
authors.affiliation: 1 Department of Anesthesiology, Tsukuba Memorial Hospital, Ibaraki, Japan.
authors.forename: Emi
authors.initials: E
authors.lastname: Tomita
authors.affiliation: 1 Department of Anesthesiology, Tsukuba Memorial Hospital, Ibaraki, Japan.
authors.forename: Hajime
authors.initials: H
authors.lastname: Takase
authors.affiliation: 1 Department of Anesthesiology, Tsukuba Memorial Hospital, Ibaraki, Japan.
authors.forename: Keiichi
authors.initials: K
authors.lastname: Tajima
authors.affiliation: 2 Department of Cardiovascular Surgery, Tsukuba Memorial Hospital, Ibaraki, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Suematsu
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001777:Blood Coagulation / Q000187:drug effects*; D001780:Blood Coagulation Tests; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects*; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006490:Hemostatics / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D018579:Patient Selection; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics; D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: Blood loss; Blood transfusion; Cardiac surgical procedures; Coagulants; Postoperative hemorrhage; Recombinant FVIIa; surgical