Individualized, Intraoperative Dosing of Fibrinogen Concentrate for the Prevention of Bleeding in Neonatal and Infant Cardiac Surgery Using Cardiopulmonary Bypass (FIBCON): A Phase 1b/2a Randomized Controlled Trial.

Circulation. Cardiovascular Interventions
Kristina SiemensShane M Tibby

Abstract

Mediastinal bleeding is common following pediatric cardiopulmonary bypass surgery for congenital heart disease. Fibrinogen concentrate (FC) represents a potential therapy for preventing bleeding. We performed a single-center, phase 1b/2a, randomized controlled trial on infants 2.5 to 12 kg undergoing cardiopulmonary bypass surgery, aimed at (1) demonstrating the feasibility of an intraoperative point-of-care test, rotational thromboelastometry, to screen out patients at low risk of postoperative bleeding and then guide individualized FC dosing in high-risk patients and (2) determining the dose, safety, and efficacy of intraoperative FC supplementation. Screening occurred intraoperatively 1-hour before bypass separation using the rotational thromboelastometry variable fibrinogen thromboelastometry maximum clot firmness (FibTEM-MCF; fibrinogen contribution to clot firmness). If FibTEM-MCF ≥7 mm, patients entered the monitoring cohort. If FibTEM-MCF ≤6 mm, patients were randomized to receive FC/placebo (2:1 ratio). Individualized FC dose calculation included weight, bypass circuit volume, hematocrit, and intraoperative measured and desired FibTEM-MCF. The coprimary outcomes, measured 5 minutes post-FC administration were FibTEM-MC...Continue Reading

References

Oct 13, 1998·The Annals of Thoracic Surgery·G D WilliamsC Ramamoorthy
Jan 30, 2008·Anesthesia and Analgesia·Nina A GuzzettaBruce E Miller
Oct 7, 2009·Journal of Thrombosis and Haemostasis : JTH·M J Manco-JohnsonUNKNOWN FIBRINOGEN CONCENTRATE STUDY GROUP
Oct 16, 2010·Journal of Thrombosis and Haemostasis : JTH·N Rahe-Meyer, B Sørensen
Jul 7, 2011·Cardiology in the Young·Jo Bønding AndreasenHanne Berg Ravn
Apr 26, 2012·European Journal of Cardio-thoracic Surgery : Official Journal of the European Association for Cardio-thoracic Surgery·David FaraoniPhilippe Van der Linden
Jun 22, 2014·The Journal of Thoracic and Cardiovascular Surgery·Filomena R B G GalasLudhmila A Hajjar
Jul 26, 2014·Acta Anaesthesiologica Scandinavica·J LundeA Afshari
Feb 5, 2016·Current Opinion in Anaesthesiology·Susan M Goobie, Thorsten Haas
Feb 26, 2016·Anesthesiology·Ashley C BrownNina A Guzzetta
Apr 4, 2017·Interactive Cardiovascular and Thoracic Surgery·Mohsen KarimiCarla Hronek
Dec 1, 2017·Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies·Kristina SiemensShane M Tibby
Jan 18, 2018·The Journal of Thoracic and Cardiovascular Surgery·Rachel S BercovitzRonald K Woods
May 12, 2019·Journal of Cardiothoracic and Vascular Anesthesia·David FaraoniBeverley J Hunt

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Citations

May 11, 2021·Frontiers in Pediatrics·Gemma Louise Crighton, Elise J Huisman
Jul 16, 2021·Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies·Sheila J HansonUNKNOWN National Heart, Lung, and Blood Institute (NHLBI) Recipient Epidemiology and Donor Evaluation Study-IV-Pediatric (REDS-IV-P)

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