Randomized, double-blinded, placebo-controlled trial Of fibrinogen concentrate supplementation after complex cardiac surgery

Marco Ranucci, Ekaterina Baryshnikova, Giulia Beatrice Crapelli, Niels Rahe-Meyer, Lorenzo Menicanti, Alessandro Frigiola, Serenella Castelvecchio, Valeria Pistuddi, Santi Trimarchi, Concetta Carlucci, Alessandro Varrica, Angela Satriano, Maria Teresa La Rovere, The Surgical Clinical Outcome REsearch (SCORE) Group

Research output: Contribution to journalArticlepeer-review

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. Methods and 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.

Original languageEnglish
Article numbere002066
JournalJournal of the American Heart Association
Volume4
Issue number6
DOIs
Publication statusPublished - 2015

Keywords

  • Cardiopulmonary bypass
  • Fibrinogen
  • Hemorrhage
  • Surgery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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