3-Factor Prothrombin Complex Concentrates in Infants With Refractory Bleeding After Cardiac Surgery

Jooste, Edmund H.; Machovec, Kelly A.; Einhorn, Lisa M.; Ames, Warwick A.; Homi, H. Mayumi; Jaquiss, Robert D.B.; Lodge, Andrew J.; Levy, Jerrold H.; Welsby, Ian J.

doi:10.1053/j.jvca.2016.01.029

Cited by 19 publications

(24 citation statements)

References 37 publications

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“…The safety and efficacy of Kcentra in the pediatric population have not been studied, and published data on its use in pediatric cardiac surgery are limited to one retrospective case series review . Data on the use of prothrombin complex concentrates in general (three‐factor or four‐factor prothrombin complex concentrates) in the pediatric cardiac population are limited and consists of a handful of small studies …”

Section: Introductionsupporting

confidence: 90%

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The use of prothrombin complex concentrate as a warfarin reversal agent in pediatric patients undergoing orthotopic heart transplantation

Sisti

Williams²,

Ding

et al. 2020

Pediatric Anesthesia

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Background Patients supported with a ventricular assist device are predisposed to severe bleeding at the time of orthotopic heart transplant due to several risk factors including anticoagulation with vitamin K antagonists. Kcentra, a four‐factor prothrombin complex concentrate, has been approved by the FDA for warfarin reversal in adults prior to urgent surgery. There is a lack of published data on the preoperative use of four‐factor prothrombin complex concentrates in pediatric patients undergoing cardiacsurgery. Methods This is a single‐center retrospective analysis of pediatric patients with a continuous‐flow ventricular assist device who underwent heart transplant, comparing patients who received Kcentra for anticoagulation reversal with a historical patient cohort who did not. Consecutive patients from January 2013 to December 2017 were analyzed. The primary outcome was volume of blood product transfusion prior to cardiopulmonary bypass initiation. Secondary outcomes include blood product transfusion after cardiopulmonary bypass intraoperatively and up to 24 hours postoperatively, chest tube output within 24 hours of surgery, time to extubation, incidence of thromboembolism, and post‐transplant length ofstay. Results From 2013 to 2017, 31 patients with continuous‐flow ventricular assist devices underwent heart transplant, with 27 patients included in the analysis. Fifteen patients received Kcentra compared with 12 patients who received fresh‐frozen plasma for anticoagulation reversal. Compared with the control group, patients who received Kcentra had less packed red blood cells, fresh‐frozen plasma, and platelets transfused prior to cardiopulmonary bypass initiation. The Kcentra group also received less packed red blood cells on bypass and less packed red blood cells after cardiopulmonary bypass termination. There were no differences in chest tube output, time to extubation, intensive care unit length of stay, or overall hospital length of stay. Neither group had thromboembolic complications detected during the first seven postoperative days. Conclusion This small retrospective study indicates that preoperative warfarin reversal with Kcentra reduces blood product exposure in pediatric patients with ventricular assist devices undergoing heart transplant.

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Section: Introductionsupporting

confidence: 90%

“…Another case series report described the use of a three‐factor prothrombin complex concentrate in six infants as a hemostatic adjunct for refractory bleeding after cardiac surgery …”

Section: Discussionmentioning

confidence: 99%

The use of prothrombin complex concentrate as a warfarin reversal agent in pediatric patients undergoing orthotopic heart transplantation

Sisti

Williams²,

Ding

et al. 2020

Pediatric Anesthesia

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“…Thus, off-label use of rFactor VIIa and other pre-haemostatic factors, such as Profilnine and Bebulin, are increasingly being used as rescue therapy interventions in complex cases following failed conventional management. 10 This can be done through adherence to a well-structured protocol that clearly outlines an algorithm of conventional treatment before the commencement of rescue therapy. Nevertheless, administration of these products is plagued with thrombotic risks, which could be life-threatening following intricate cardiac surgery.…”

Section: Discussionmentioning

confidence: 99%

Management of refractory bleeding post-cardiopulmonary bypass in an acute heparin-induced thrombocytopenia type II renal failure patient who underwent urgent cardiac surgery with bivalirudin (Angiox^®) anticoagulation

et al. 2017

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Acute heparin-induced thrombocytopenia (HIT) patients present a myriad of anticoagulation management challenges, in clinical settings where unfractionated heparin (UFH) is the traditional drug of choice. UFH use in cardiac surgery is a known entity that has been subject to rigorous research. Research has, thus, led to its unparalleled use and the development of well-established protocols for cardiac surgery. In comparison to UFH, bivalirudin use for acute HIT patients requiring urgent cardiac surgery with cardiopulmonary bypass (CPB) is still in its infancy. We describe the tailored post-CPB management of refractory bleeding in a 65-year-old infective endocarditis, acute HIT patient with renal failure who underwent urgent aortic valve replacement and mitral valve repair with bivalirudin anticoagulation. A management approach that entailed a combination of continuous venovenous haemofiltration (CVVH), 4-Factor prothrombin complex concentrate (PCC) (Beriplex), recombinant factor VIIa (rFactor VIIa) and desmopressin (DDAVP) were consecutively used post-operatively in theatre. Based on this case study experience, two modifications to institutional protocols are recommended. The first is the use of CVVH in theatre to eliminate bivalirudin in renal failure patients or in patients where bivalirudin elimination is prolonged. Secondly, a 'rescue therapy/intervention' algorithm for the swift identification of refractory bleeding post-CPB is also recommended. Rescue therapy agents, such as a 4-Factor PCCs and rFactor VIIa, should be incorporated into the protocol after a robust evidence-based search and agreement with the haematologist. The aim of these recommendations is to reduce the risk of bleeding associated with bivalirudin use for inexperienced institutions and experienced institutions alike, until larger randomized, controlled studies provide more in-depth knowledge to expand our clinical practice.

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“…Of note, in this institution, replacement of antithrombin is routinely performed in all neonates if the level is less 70%. Hemostasis was eventually achieved, but 2 of the study patients had thrombotic complications [55].…”

Section: Pcc Use In Pediatric Cardiac Surgical Patientsmentioning

confidence: 96%

Prothrombin Complex Concentrates in Pediatric Cardiac Surgery: The Current State and the Future

Ashikhmina

Said

Smith

et al. 2017

The Annals of Thoracic Surgery

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3-Factor Prothrombin Complex Concentrates in Infants With Refractory Bleeding After Cardiac Surgery

Cited by 19 publications

References 37 publications

The use of prothrombin complex concentrate as a warfarin reversal agent in pediatric patients undergoing orthotopic heart transplantation

The use of prothrombin complex concentrate as a warfarin reversal agent in pediatric patients undergoing orthotopic heart transplantation

Management of refractory bleeding post-cardiopulmonary bypass in an acute heparin-induced thrombocytopenia type II renal failure patient who underwent urgent cardiac surgery with bivalirudin (Angiox^®) anticoagulation

Prothrombin Complex Concentrates in Pediatric Cardiac Surgery: The Current State and the Future

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3-Factor Prothrombin Complex Concentrates in Infants With Refractory Bleeding After Cardiac Surgery

Cited by 19 publications

References 37 publications

The use of prothrombin complex concentrate as a warfarin reversal agent in pediatric patients undergoing orthotopic heart transplantation

The use of prothrombin complex concentrate as a warfarin reversal agent in pediatric patients undergoing orthotopic heart transplantation

Management of refractory bleeding post-cardiopulmonary bypass in an acute heparin-induced thrombocytopenia type II renal failure patient who underwent urgent cardiac surgery with bivalirudin (Angiox®) anticoagulation

Prothrombin Complex Concentrates in Pediatric Cardiac Surgery: The Current State and the Future

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Management of refractory bleeding post-cardiopulmonary bypass in an acute heparin-induced thrombocytopenia type II renal failure patient who underwent urgent cardiac surgery with bivalirudin (Angiox^®) anticoagulation