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

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.

• Authors: Niels Rahe-Meyer, Alexander Hanke, Dirk S Schmidt, Christian Hagl, Maximilian Pichlmaier
• Journal: The Journal of thoracic and cardiovascular surgery (J Thorac Cardiovasc Surg) Vol. 145 Issue 3 Suppl Pg. S178-85 (Mar 2013) ISSN: 1097-685X [Electronic] United States
• PMID: 23410777 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2013. Published by Mosby, Inc.

Chemical References

• Hemostatics
• Fibrinogen

Topics

• Afibrinogenemia (blood, complications, therapy)
• Algorithms
• Aorta, Thoracic (surgery)
• Blood Loss, Surgical (prevention & control)
• Blood Vessel Prosthesis Implantation (adverse effects)
• Cardiopulmonary Bypass (adverse effects)
• Double-Blind Method
• Female
• Fibrinogen (administration & dosage)
• Germany
• Hemostatic Techniques
• Hemostatics (administration & dosage)
• Humans
• Intraoperative Care
• Linear Models
• Male
• Middle Aged
• Plasma
• Platelet Transfusion
• Prospective Studies
• Thrombelastography
• Treatment Outcome