Safety of antifibrinolytics in 6583 pediatric patients having craniosynostosis surgery: A decade of data reported from the multicenter Pediatric Craniofacial Collaborative Group. Issue 12 (16th August 2022)

• Record Type: Journal Article
• Authors: King, Michael R.; Staffa, Steven J.; Stricker, Paul A.; Pérez‐Pradilla, Carolina; Nelson, Olivia; Benzon, Hubert A.; Goobie, Susan M.
• Other Names: Abruzzese Christopher investigator.; Asmal Imraan investigator.; Bailey Katherine investigator.; Barker Nigel investigator.; Bhandari Angelina investigator.; Beethe Amy investigator.; Binstock Wendy investigator.; van den Bosch Chloe investigator.; Bradford Victoria investigator.; Bradley James investigator.; Bryan Kayla investigator.; Brzenski Alyssa investigator.; Budac Stefan investigator.; Busso Veronica investigator.; de Castro Alexa investigator.; Castro‐Frenzel Karla investigator.; Chhabada Surendrasingh investigator.; Chiao Franklin investigator.; Ching Jessica investigator.; Cladis Franklyn investigator.; Claypool Danielle investigator.; Collins Michael investigator.; Correll Lynnie investigator.; Costandi Andrew investigator.; Dabek Rachel investigator.; Dalesio Nicholas investigator.; Downard Martina investigator.; Echeverry Piedad investigator.; Edala Thejovathi investigator.; Edwards Christopher investigator.; Ellison Pavithra R. investigator.; Enicker Basil investigator.; Falcon Ricardo investigator.; Fernandez Allison investigator.; Fernandez Patrick investigator.; Fiadjoe John investigator.; Franzen Marcellene investigator.; Gangadharan Meera investigator.; Glover Chris investigator.; Gosman Amanda investigator.; Governale Lance investigator.; Grivoyannis Anastasia investigator.; Grap Shannon investigator.; Gries Heike investigator.; Griffin Allison investigator.; Hajduk John investigator.; Haas Thorsten investigator.; Hansen Jennifer investigator.; Hetmaniuk Mali investigator.; Homi H. Mayumi investigator.; Hsieh Hannah investigator.; Hsieh Vincent investigator.; Huang Henry investigator.; Ingelmo Pablo investigator.; Ivanova Iskra investigator.; Jain Ranu investigator.; Kamel George investigator.; Kanmanthreddy Siri investigator.; Kars Michelle investigator.; Koller John investigator.; Kowalczyk‐Derderian Courtney investigator.; Kugler Jane investigator.; Labovsky Kristen investigator.; Lakheeram Indrani investigator.; Lazar Alina investigator.; Lee Andrew investigator.; Lee Jennifer investigator.; Madaree Anil investigator.; Malviya Shobha investigator.; Martinez Jose Luis investigator.; Mason Aaron investigator.; Medellin Eduardo investigator.; Mehta Vivek investigator.; Meier Petra M. investigator.; Levy Heather Mitzel investigator.; Mueller Martin investigator.; Muhly Wallis T. investigator.; Muldowney Bridget investigator.; Nause‐Osthoff Rebecca investigator.; Nelson Jonathon investigator.; Nicholson Julie investigator.; Nguyen Kim‐Phuong investigator.; Nguyen Thanh investigator.; Owens‐Stubblefield Margaret investigator.; Pankratz Matt investigator.; Parekh Uma Ramesh investigator.; Parikh Mihir investigator.; Patel Jasmine investigator.; Patel Roshan investigator.; Patel Vikram investigator.; Petersen Timothy investigator.; Post Julian investigator.; Poteet‐Schwartz Kim investigator.; Puglia Michael P. investigator.; Reddy Srijaya K. investigator.; Reid Russell investigator.; Ricketts Karene investigator.; McCormick Megan Rodgers investigator.; Ryan Laura investigator.; Sbrollini Kaitlyn investigator.; Seidman Peggy investigator.; Seubert Christoph investigator.; Salik Irim investigator.; Singh Davinder J. investigator.; Singhal Neil R. investigator.; Skitt Rochelle investigator.; Soneru Codruta investigator.; Sorial Emad investigator.; Starker Elizabeth investigator.; Stubbeman Bobbie investigator.; Sunder Rani investigator.; Sung Wai investigator.; Syed Tariq investigator.; Szmuk Peter investigator.; Taicher Brad M. investigator.; Taylor Jenna investigator.; Taylor Kimberly investigator.; Thompson Douglas investigator.; Titler Sarah S. investigator.; Ungar‐Kastner Galit investigator.; Whyte Simon investigator.; Wong Alvin investigator.; Wong Karen investigator.; Yates Hannah investigator.; Zamora Lillian investigator.;
• Is Part Of: Paediatric anaesthesia. Volume 32:Issue 12(2022)
• Page Start: 1339
• Page End: 1346
• Publication Date: 2022-08-16
• Subjects: antifibrinolytic -- craniofacial surgery -- craniosynostosis -- epsilon‐aminocaproic acid -- patient blood management -- pediatrics -- tranexamic acid; Pediatric anesthesia -- Periodicals; 617.96798
• DOI: 10.1111/pan.14540
• Languages: English
• ISSNs: 1155-5645

Abstract

Abstract: Background: Antifibrinolytics such as tranexamic acid and epsilon‐aminocaproic acid are effective at reducing blood loss and transfusion in pediatric patients having craniofacial surgery. The Pediatric Craniofacial Collaborative Group has previously reported low rates of seizures and thromboembolic events (equal to no antifibrinolytic given) in open craniofacial surgery. Aims: To query the Pediatric Craniofacial Collaborative Group database to provide an updated antifibrinolytic safety profile in children given that antifibrinolytics have become recommended standard of care in this surgical population. Additionally, we include the population of younger infants having minimally invasive procedures. Methods: Patients in the Pediatric Craniofacial Collaborative Group registry between June 2012 and March 2021 having open craniofacial surgery (fronto‐orbital advancement, mid and posterior vault, total cranial vault remodeling, intracranial LeFort III monobloc), endoscopic cranial suture release, and spring mediated cranioplasty were included. The primary outcome is the rate of postoperative complications possibly attributable to antifibrinolytic use (seizures, seizure‐like activity, and thromboembolic events) in infants and children undergoing craniosynostosis surgery who did or did not receive antifibrinolytics. Results: Forty‐five institutions reporting 6583 patients were included. The overall seizure rate was 0.24% (95% CI: 0.14, 0.39%), with 0.20% in the no Antifibrinolytic group and 0.26% in the combined Antifibrinolytic group, with no statistically reported difference. Comparing seizure rates between tranexamic acid (0.22%) and epsilon‐aminocaproic acid (0.44%), there was no statistically significant difference (odds ratio = 2.0; 95% CI: 0.6, 6.7; p = .257). Seizure rate was higher in patients greater than 6 months (0.30% vs. 0.18%; p = .327), patients undergoing open procedures (0.30% vs. 0.06%; p = .141), and syndromic patients (0.70% vs. 0.19%; p = .009). Conclusions: This multicenter international experience of pediatric craniofacial surgery reports no increase in seizures or thromboembolic events in those that received antifibrinolytics (tranexamic acid and epsilon‐aminocaproic acid) versus those that did not. This report provides further evidence of antifibrinolytic safety. We recommend following pharmacokinetic‐based dosing guidelines for administration.