title: Randomized, double-blinded, placebo-controlled trial of fibrinogen concentrate supplementation after complex cardiac surgery.
abstract: BACKGROUND
  Postoperative bleeding after heart operations is still a common finding, leading to allogeneic blood products transfusion. Fibrinogen and coagulation factors deficiency are possible determinants of bleeding. The experimental hypothesis of this study is that a first-line fibrinogen supplementation avoids the need for fresh frozen plasma (FFP) and reduces the need for any kind of transfusions.
  
  
  RESULTS
  This was a single-center, prospective, randomized, placebo-controlled, double-blinded study. One-hundred sixteen patients undergoing heart surgery with an expected cardiopulmonary bypass duration >90 minutes were admitted to the study. Patients in the treatment arm received fibrinogen concentrate after protamine administration; patients in the control arm received saline solution. In case of ongoing bleeding, patients in the treatment arm could receive prothrombin complex concentrates (PCCs) and those in the control arm saline solution. The primary endpoint was avoidance of any allogeneic blood product. Patients in the treatment arm had a significantly lower rate of any allogeneic blood products transfusion (odds ratio, 0.40; 95% confidence interval, 0.19 to 0.84, P=0.015). The total amount of packed red cells and FFP units transfused was significantly lower in the treatment arm. Postoperative bleeding was significantly (P=0.042) less in the treatment arm (median, 300 mL; interquartile range, 200 to 400 mL) than in the control arm (median, 355 mL; interquartile range, 250 to 600 mL).
  
  
  CONCLUSIONS
  Fibrinogen concentrate limits postoperative bleeding after complex heart surgery, leading to a significant reduction in allogeneic blood products transfusions. No safety issues were raised.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01471730.
authors.affiliation: Department of Cardiothoracic, Vascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy (M.R., E.B., G.B.C.).
authors.forename: Marco
authors.initials: M
authors.lastname: Ranucci
authors.affiliation: Department of Cardiothoracic, Vascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy (M.R., E.B., G.B.C.).
authors.forename: Ekaterina
authors.initials: E
authors.lastname: Baryshnikova
authors.affiliation: Department of Cardiothoracic, Vascular Anesthesia and Intensive Care, IRCCS Policlinico San Donato, Milan, Italy (M.R., E.B., G.B.C.).
authors.forename: Giulia Beatrice
authors.initials: GB
authors.lastname: Crapelli
authors.affiliation: Clinic for Anesthesiology and Intensive Care Medicine, Hannover Medical School, Hannover, Germany (N.R.M.).
authors.forename: Niels
authors.initials: N
authors.lastname: Rahe-Meyer
authors.affiliation: Department of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy (L.M., A.F.).
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Menicanti
authors.affiliation: Department of Cardiac Surgery, IRCCS Policlinico San Donato, Milan, Italy (L.M., A.F.).
authors.forename: Alessandro
authors.initials: A
authors.lastname: Frigiola
mesh_terms: D000368:Aged; D001780:Blood Coagulation Tests; D001803:Blood Transfusion / Q000706:statistics & numerical data; D006348:Cardiac Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005340:Fibrinogen / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019106:Postoperative Hemorrhage / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D005340:Fibrinogen
keywords: cardiopulmonary bypass; fibrinogen; hemorrhage; surgery