PB0656 - Dosing, monitoring, and clinical outcomes of fibrinogen concentrate administration in pediatric cardiac surgery patients undergoing cardiopulmonary bypass

Monday, June 24, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Presenting Author(s)

Amy Kiskaddon, PharmD, MBA

Assistant Professor of Pediatrics
Johns Hopkins University, Florida, United States

Co-Author(s)

CJ

Cassandra Josephson

Professor, Oncology, Pediatrics, and Pathology
Johns Hopkins University School of Medicine
Saint Petersburg, Florida, United States
Neil Goldenberg, MD,PhD

Departments of Pediatrics and Medicine
Johns Hopkins University School of Medicine, Baltimore, MD; Clinical and Data Coordinating Center for Pediatric Multicenter Studies, Johns Hopkins All Children’s Institute for Clinical and Translational Research, St. Petersburg, FL
Saint Petersburg, Florida, United States
Vera Ignjatovic, PhD, MBA

Professor of Pediatrics
Johns Hopkins All Children's Institute for Clinical and Translational Research; Department of Pediatrics, School of Medicine, Johns Hopkins University, United States
St Petersburg, Florida, United States
VK

Vyas Kartha

Assistant Professor, Anesthesia and Critical Care
Johns Hopkins All Childrens Hospital
Saint Petersburg, Florida, United States

Background: Acquired hypofibrinogenemia occurs during adult and pediatric cardiac surgery, and may be managed with fibrinogen-containing products to treat/prevent bleeding complications. Fibrinogen concentrate (FC) administration has demonstrated to be non-inferior to cryoprecipitate transfusion in adult cardiac surgery patients with bleeding secondary to hypofibrinogenemia. FC has advantages in pediatrics compared to cryoprecipitate given small volume, decreased immunogenicity/infectious risks, and accessibility. Limited data have been published on FC dosing/outcomes in pediatric cardiac surgery patients.

Aims: To describe dosing, laboratory monitoring, and thromboembolic (TE) complications of FC administration in pediatric cardiac surgery.

Methods: A retrospective review (IRB approved) of patients aged < 18 years undergoing cardiac surgery from November 2021-December 2023 who received FC as part of an institutional protocol (pre- and post-cardiopulmonary bypass TEG and fibrinogen levels guide blood products and/or fibrinogen concentrate administration). Data collection included FC dose, fibrinogen levels before and after FC, intra- and post-op blood product administration, chest tube output (mL/kg/hr), length of stay, and TE. Descriptive statistics were employed.

Results: Thirty children undergoing pediatric cardiac surgery received FC. The median (IQR) age and weight were 3 (0.2-4.9) months and 4.2 (3.2-5.9) kg. Most patients (n=17, 56.7%) had one 50 mg/kg/dose, 7 (23.3%) had a 75 mg/kg/dose, and 6 (20%) had ≥100 mg/kg/dose. A FC dose of 50 mg/kg increased median (IQR) fibrinogen levels by 129 (79-178), with a correction factor of 1.9 (1.4-2.6). The median (IQR) 24-hour post-op chest tube output was 1.3 (1-1.6) mL/kg/hr. Two (6.7%) patients developed TE (1 upper venous, 1 lower venous) following surgery. Although 7 patients had a thrombosis history, none developed TE following FC.

Conclusion(s): These retrospective findings suggest that FC may be utilized to manage acquired hypofibrinogenemia in pediatric cardiac surgery patients. Prospective studies would further establish dosing, safety, and efficacy.