Use of human fibrinogen concentrate during proximal aortic reconstruction with deep hypothermic circulatory arrest

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 151; no. 2; pp. 376 - 382
• Main Authors: Hanna, Jennifer M., MD, MBA, Keenan, Jeffrey E., MD, Wang, Hanghang, MD, Andersen, Nicholas D., MD, Gaca, Jeffrey G., MD, Lombard, Frederick W., MB, ChB, Welsby, Ian J., MBBS, FRCA, Hughes, G. Chad, MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-02-2016
• Subjects: Adult; anesthesia; Aorta - surgery; aortic reconstruction; bleeding; blood coagulation; Blood Loss, Surgical - prevention & control; Blood Transfusion; Blood Vessel Prosthesis Implantation - adverse effects; Cardiothoracic Surgery; circulatory arrest; Circulatory Arrest, Deep Hypothermia Induced - adverse effects; coagulopathy; deep hypothermia; Elective Surgical Procedures; Female; fibrinogen; Fibrinogen - administration & dosage; Fibrinogen - adverse effects; Hemostatics - administration & dosage; Hemostatics - adverse effects; Humans; Male; Middle Aged; North Carolina; Pilot Projects; Plastic Surgery Procedures - adverse effects; Postoperative Hemorrhage - prevention & control; Prospective Studies; Time Factors; Treatment Outcome; North Carolina; aortic reconstruction; blood transfusion; FDA; bleeding; fibrinogen; HFC; blood coagulation; PRBC; deep hypothermic circulatory arrest; coagulopathy; anesthesia; packed red blood cells; circulatory arrest; CPB; deep hypothermia; cardiopulmonary bypass; DHCA; Food and Drug Administration; human fibrinogen concentrate
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/j.jtcvs.2015.08.079

Abstract Objective Human fibrinogen concentrate (HFC) is approved by the Food and Drug Administration for use at 70 mg/kg to treat congenital afibrinogenemia. We sought to determine whether this dose of HFC increases fibrinogen levels in the setting of high-risk bleeding associated with aortic reconstruction and deep hypothermic circulatory arrest (DHCA). Methods This was a prospective, pilot, off-label study in which 22 patients undergoing elective proximal aortic reconstruction with DHCA were administered 70 mg/kg HFC upon separation from cardiopulmonary bypass (CPB). Fibrinogen levels were measured at baseline, just before, and 10 minutes after HFC administration, on skin closure, and the day after surgery. The primary study outcome was the difference in fibrinogen level immediately after separation from CPB, when HFC was administered, and the fibrinogen level 10 minutes following HFC administration. Additionally, postoperative thromboembolic events were assessed as a safety analysis. Results The mean baseline fibrinogen level was 317 ± 49 mg/dL and fell to 235 ± 39 mg/dL just before separation from CPB. After HFC administration, the fibrinogen level rose to 331 ± 41 mg/dL ( P  < .001) and averaged 372 ± 45 mg/dL the next day. No postoperative thromboembolic complications occurred. Conclusions Administration of 70 mg/kg HFC upon separation from CPB raises fibrinogen levels by approximately 100 mg/dL without an apparent increase in thrombotic complications during proximal aortic reconstruction with DHCA. Further prospective study in a larger cohort of patients will be needed to definitively determine the safety and evaluate the efficacy of HFC as a hemostatic adjunct during these procedures.