Document Detail

Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: Results from a randomized, placebo-controlled trial.
MedLine Citation:
PMID:  23410777     Owner:  NLM     Status:  In-Data-Review    
OBJECTIVES: 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.
Niels Rahe-Meyer; Alexander Hanke; Dirk S Schmidt; Christian Hagl; Maximilian Pichlmaier
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Publication Detail:
Type:  Editorial    
Journal Detail:
Title:  The Journal of thoracic and cardiovascular surgery     Volume:  145     ISSN:  1097-685X     ISO Abbreviation:  J. Thorac. Cardiovasc. Surg.     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0376343     Medline TA:  J Thorac Cardiovasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S178-85     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013. Published by Mosby, Inc.
Clinic for Anesthesiology and Intensive Care Medicine, Franziskus Hospital, Bielefeld, Germany; Clinic for Anesthesiology and Intensive Care Medicine, Hannover Medical School, Hannover, Germany. Electronic address:
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