title: Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial.
abstract: BACKGROUND
  Fibrinogen is suggested to play an important role in managing major bleeding. However, clinical evidence regarding the effect of fibrinogen concentrate (derived from human plasma) on transfusion is limited. The authors assessed whether fibrinogen concentrate can reduce blood transfusion when given as intraoperative, targeted, first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery.
  
  
  METHODS
  In this single-center, prospective, placebo-controlled, double-blind study, patients aged 18 yr or older undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to fibrinogen concentrate or placebo, administered intraoperatively. Study medication was given if patients had clinically relevant coagulopathic bleeding immediately after removal from cardiopulmonary bypass and completion of surgical hemostasis. Dosing was individualized using the fibrin-based thromboelastometry test. If bleeding continued, a standardized transfusion protocol was followed.
  
  
  RESULTS
  Twenty-nine patients in the fibrinogen concentrate group and 32 patients in the placebo group were eligible for the efficacy analysis. During the first 24 h after the administration of study medication, patients in the fibrinogen concentrate group received fewer allogeneic blood components than did patients in the placebo group (median, 2 vs. 13 U; P < 0.001; primary endpoint). Total avoidance of transfusion was achieved in 13 (45%) of 29 patients in the fibrinogen concentrate group, whereas 32 (100%) of 32 patients in the placebo group received transfusion (P < 0.001). There was no observed safety concern with using fibrinogen concentrate during aortic surgery.
  
  
  CONCLUSIONS
  Hemostatic therapy with fibrinogen concentrate in patients undergoing aortic surgery significantly reduced the transfusion of allogeneic blood products. Larger multicenter studies are necessary to confirm the role of fibrinogen concentrate in the management of perioperative bleeding in patients with life-threatening coagulopathy.
authors.affiliation: Clinic for Anesthesiology and Intensive Care Medicine, Franziskus Hospital, Bielefeld, Germany. niels.rahe-meyer@franziskus.de
authors.forename: Niels
authors.initials: N
authors.lastname: Rahe-Meyer
authors.forename: Cristina
authors.initials: C
authors.lastname: Solomon
authors.forename: Alexander
authors.initials: A
authors.lastname: Hanke
authors.forename: Dirk S
authors.initials: DS
authors.lastname: Schmidt
authors.forename: Dietrich
authors.initials: D
authors.lastname: Knoerzer
authors.forename: Gerald
authors.initials: G
authors.lastname: Hochleitner
authors.forename: Benny
authors.initials: B
authors.lastname: Sørensen
authors.forename: Christian
authors.initials: C
authors.lastname: Hagl
authors.forename: Maximilian
authors.initials: M
authors.lastname: Pichlmaier
mesh_terms: D001011:Aorta / Q000601:surgery*; D001803:Blood Transfusion; D002315:Cardiopulmonary Bypass / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000627:therapeutic use*; D006488:Hemostasis, Surgical / Q000379:methods; D006490:Hemostatics / Q000627:therapeutic use*; D006801:Humans; D007430:Intraoperative Care / Q000379:methods*; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics; D005340:Fibrinogen