title: Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial.
abstract: OBJECTIVE
  We assessed whether fibrinogen concentrate as targeted first-line hemostatic therapy was more effective than placebo or a standardized transfusion algorithm in controlling coagulopathic bleeding in patients undergoing major aortic surgery.
  
  
  METHODS
  In this single-center, prospective, double-blind study, adults undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to intraoperative fibrinogen concentrate (n = 29) or placebo (n = 32). Study medication was given if patients had clinically relevant coagulopathic bleeding, measured by 5-minute bleeding mass, after cardiopulmonary bypass removal, protamine administration, and surgical hemostasis. Fibrinogen concentrate dosing was individualized using the thromboelastometric FIBTEM test. If bleeding continued, a standardized transfusion algorithm was followed. In the placebo group, all 32 patients received 1 transfusion cycle of fresh-frozen plasma/platelets, and 30 patients required a second transfusion cycle; none of these patients received any other procoagulant therapy. Change in bleeding rate after treatment was compared using t tests.
  
  
  RESULTS
  Mean change in bleeding rate after fibrinogen concentrate was -48.3 g/5 min, compared with 0.4 g/5 min after placebo (P < .001), -16.1 g/5 min after 1 transfusion cycle (fresh-frozen plasma or platelets; P = .003), and -28.0 g/5 min after 2 transfusion cycles (fresh-frozen plasma and platelets; P = .11). Reductions in bleeding rate were greater for patients with higher bleeding rates before treatment, especially with fibrinogen concentrate.
  
  
  CONCLUSIONS
  FIBTEM-guided intraoperative hemostatic therapy with fibrinogen concentrate is more effective than placebo in controlling coagulopathic bleeding during major aortic replacement surgery. Fibrinogen concentrate is also more effective than 1 cycle of fresh-frozen plasma/platelets and is more rapid than--and at least as effective as--2 cycles of fresh-frozen plasma/platelets.
authors: Clinic for Anesthesiology and Intensive Care Medicine, Franziskus Hospital, Bielefeld, Germany. Niels.Rahe-Meyer@franziskus.de
authors: Niels
authors: N
authors: Rahe-Meyer
authors: Alexander
authors: A
authors: Hanke
authors: Dirk S
authors: DS
authors: Schmidt
authors: Christian
authors: C
authors: Hagl
authors: Maximilian
authors: M
authors: Pichlmaier
mesh_terms: D000347:Afibrinogenemia / Q000097:blood / Q000150:complications / Q000628:therapy*; D000465:Algorithms; D001013:Aorta, Thoracic / Q000601:surgery*; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects*; D002315:Cardiopulmonary Bypass / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000008:administration & dosage*; D005858:Germany; D006489:Hemostatic Techniques; D006490:Hemostatics / Q000008:administration & dosage*; D006801:Humans; D007430:Intraoperative Care; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010949:Plasma; D017713:Platelet Transfusion; D011446:Prospective Studies; D013916:Thrombelastography; D016896:Treatment Outcome
chemical_list: D006490:Hemostatics; D005340:Fibrinogen