4-Factor Prothrombin Complex Concentrate (PCC4, Kcentra®) Protocol Reduces Blood Requirements for Heart Transplantation: A Novel Protocol

Cleary, Jacqueline Pratt; Hodge, Laura; Palmer, Brittany; Barreiro, Christopher J.; Ingemi, Amanda I.

doi:10.12659/aot.898496

Cited by 11 publications

(3 citation statements)

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“…Moreover, a lack of homogeneity among studies regarding timing and dosing of the prothrombin complex concentrate precludes any meta‐analysis. However, data with modern four‐factor prothrombin complex concentrate quite universally demonstrate a reduced need for red blood cell transfusion in comparison with FFP [30–33]. A similar trend towards an increased use of a four‐factor prothrombin complex concentrate can be observed in patients undergoing implantation of a durable left ventricular assist device or major urgent surgery following implantation [35–37].…”

Section: Vitamin K Antagonist Reversalmentioning

confidence: 92%

“…After the more recent introduction of the four‐factor prothrombin complex concentrate in the USA, many publications reflect its emerging use in this circumstance. However, only non‐prospective and non‐randomised studies, for example, comparison with historical controls or pre‐ and post‐introduction of four‐factor prothrombin complex concentrate into clinical practice, are available [30–34]. Viewing the inherent limitation of patient numbers for this special indication, no statistical tools for risk adjustment were used.…”

Section: Vitamin K Antagonist Reversalmentioning

confidence: 99%

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A European consensus statement on the use of four‐factor prothrombin complex concentrate for cardiac and non‐cardiac surgical patients

et al. 2020

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Summary Modern four‐factor prothrombin complex concentrate was designed originally for rapid targeted replacement of the coagulation factors II, VII, IX and X. Dosing strategies for the approved indication of vitamin K antagonist‐related bleeding vary greatly. They include INR and bodyweight‐related protocols as well as fixed dose regimens. Particularly in the massively bleeding trauma and cardiac surgery patient, four‐factor prothrombin complex concentrate is used increasingly for haemostatic resuscitation. Members of the Transfusion and Haemostasis Subcommittee of the European Association of Cardiothoracic Anaesthesiology performed a systematic literature review on four‐factor prothrombin complex concentrate. The available evidence has been summarised for dosing, efficacy, drug safety and monitoring strategies in different scenarios. Whereas there is evidence for the efficacy of four‐factor prothrombin concentrate for a variety of bleeding scenarios, convincing safety data are clearly missing. In the massively bleeding patient with coagulopathy, our group recommends the administration of an initial bolus of 25 IU.kg‐1. This applies for: the acute reversal of vitamin K antagonist therapy; haemostatic resuscitation, particularly in trauma; and the reversal of direct oral anticoagulants when no specific antidote is available. In patients with a high risk for thromboembolic complications, e.g. cardiac surgery, the administration of an initial half‐dose bolus (12.5 IU.kg‐1) should be considered. A second bolus may be indicated if coagulopathy and microvascular bleeding persists and other reasons for bleeding are largely ruled out. Tissue‐factor‐activated, factor VII‐dependent and heparin insensitive point‐of‐care tests may be used for peri‐operative monitoring and guiding of prothrombin complex concentrate therapy.

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Section: Vitamin K Antagonist Reversalmentioning

confidence: 92%

Section: Vitamin K Antagonist Reversalmentioning

confidence: 99%

A European consensus statement on the use of four‐factor prothrombin complex concentrate for cardiac and non‐cardiac surgical patients

et al. 2020

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“…In pediatric cardiac surgery, PCC has been previously described for reversal of vitamin K antagonists prior to cardiac transplant. 17 18 19 20 In a study of 14 pediatric patients undergoing CPB, Giorni et al reported that a PCC dose of approximately 25 IU/kg for bleeding control reduced postoperative bleeding and blood product administration without major side effects. 21 Additional case reports and studies describe the use of PCC in pediatric cardiac surgery to prevent or control bleeding.…”

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confidence: 99%

Dosing, Monitoring, Blood Product Utilization, and Thromboembolic Complications of Four-Factor Prothrombin Complex Concentrate as Part of an Institutional Protocol in Pediatric Cardiac Surgery: A Retrospective Cohort Study

Kiskaddon,

Goldenberg,

Fierstein

et al. 2023

Semin Thromb Hemost

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Pediatric cardiac surgery patients are predisposed to blood loss. Blood product administration can lead to complications. Prothrombin complex concentrates (PCCs) offer potential advantages of factor composition, small volume, decreased immunogenicity/infectious risks, and accessibility. The objective of this study was to describe dosing, monitoring, blood product utilization, and thromboembolic complications of administering four-factor PCC (4F-PCC) in pediatric cardiac surgery. We performed a retrospective review of patients aged <18 years undergoing cardiac surgery from June 2020 to May 2022 (inclusive) who received 4F-PCC. Outcomes of interest included 4F-PCC dosing (units/kg) and number of doses administered, chest tube output, blood product administration, donor exposure, length of stay, and thromboembolic events. Eighty-six patients met eligibility criteria. The median (range) age and weight were 0.37 (0.01–16.3) years and 5.3 (1.6–98) kg, respectively. Median (range) total 4F-PCC dose per patient was 25 (9.2–50) units/kg, with 6 patients (7%) receiving a total of two doses. Median (range) 24-hour postoperative packed red blood cells, platelet, plasma, and cryoprecipitate administration volumes were 0 (0–2.57) mL/kg/24 h, 0 (0–1.09), 0 (0–2.64), and 0 (0–0.28 mL/kg/24 h), respectively. Median (range) length of stay and 24-hour postoperative chest tube output were 10 (6–26) days and 1.1 (0.1–4.2) mL/kg/h, respectively. Two (2%) patients experienced a thromboembolic event within 30 days of 4F-PCC administration. These retrospective findings suggest no worsening of hemostatic parameters, a mild median improvement in fibrinogen, low blood product utilization, and low thromboembolism rates following 4F-PCC use in pediatric cardiac surgery.

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Anesthetic management of the patient undergoing heart transplantation

Nguyen

Banks

2017

Best Practice & Research Clinical Anaesthesiology

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4-Factor Prothrombin Complex Concentrate (PCC4, Kcentra®) Protocol Reduces Blood Requirements for Heart Transplantation: A Novel Protocol

Cited by 11 publications

References 0 publications

A European consensus statement on the use of four‐factor prothrombin complex concentrate for cardiac and non‐cardiac surgical patients

A European consensus statement on the use of four‐factor prothrombin complex concentrate for cardiac and non‐cardiac surgical patients

Dosing, Monitoring, Blood Product Utilization, and Thromboembolic Complications of Four-Factor Prothrombin Complex Concentrate as Part of an Institutional Protocol in Pediatric Cardiac Surgery: A Retrospective Cohort Study

Anesthetic management of the patient undergoing heart transplantation

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