Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage

Lorenz, Reinhard; Kienast, Joachim; Otto, Ulrich; Egger, K; Kiehl, Michael; Schreiter, D.; Kwasny, Harald; Haertel, Sabine; Barthels, Monika

doi:10.1097/00042737-200301000-00004

Cited by 83 publications

(76 citation statements)

References 14 publications

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“…FFP is also associated with a risk of allergic reactions, such as skin rash, pruritus, urticaria, bronchospasm, angioedema and anaphylactic shock [40]. Studies have shown that infusion of FFP is associated with increased risk and frequency of hospital-acquired infections [41], and that there is a small potential risk of disease transmission with human plasma [5]. In contrast, PCC manufacture includes at least one step of viral reduction or elimination, which minimises the risk of transmitting infectious agents.…”

Section: Comparing Pccs With Human Plasmamentioning

confidence: 99%

“…Furthermore, chronic liver disease - which was identified as a risk factor for thrombotic complications in haemophilia patients treated with earlier formulations of PCCs [12] - frequently causes a reduction in the production of antithrombin as well as coagulation factors [49]. To avoid thrombotic complications, monitoring of antithrombin activity and co-administration of antithrombin concentrate should be considered when administering PCCs to patients with severe liver disease [5]. Patients with low levels of endogenous antithrombin are likely to be at increased risk of thrombosis.…”

Section: Possible Means Of Reducing Thrombotic Riskmentioning

confidence: 99%

“…Emergency reversal of anticoagulation is most commonly needed to control bleeding as quickly as possible. The use of PCCs has also been proposed in severe liver disease and in perioperative and traumarelated bleeding [5-8], although fewer studies have been performed in these settings than for anticoagulation reversal.…”

Section: Introductionmentioning

confidence: 99%

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Clinical review: Prothrombin complex concentrates - evaluation of safety and thrombogenicity

et al. 2011

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Prothrombin complex concentrates (PCCs) are used mainly for emergency reversal of vitamin K antagonist therapy. Historically, the major drawback with PCCs has been the risk of thrombotic complications. The aims of the present review are to examine thrombotic complications reported with PCCs, and to compare the safety of PCCs with human fresh frozen plasma. The risk of thrombotic complications may be increased by underlying disease, high or frequent PCC dosing, and poorly balanced PCC constituents. The causes of PCC thrombogenicity remain uncertain but accumulating evidence indicates the importance of factor II (prothrombin). With the inclusion of coagulation inhibitors and other manufacturing improvements, today's PCCs may be considered safer than earlier products. PCCs may be considered preferable to fresh frozen plasma for emergency anticoagulant reversal, and this is reflected in the latest British and American guidelines. Care should be taken to avoid excessive substitution with prothrombin, however, and accurate monitoring of patients' coagulation status may allow thrombotic risk to be reduced. The risk of a thrombotic complication due to treatment with PCCs should be weighed against the need for rapid and effective correction of coagulopathy.

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Section: Comparing Pccs With Human Plasmamentioning

confidence: 99%

Section: Possible Means Of Reducing Thrombotic Riskmentioning

confidence: 99%

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Clinical review: Prothrombin complex concentrates - evaluation of safety and thrombogenicity

et al. 2011

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“…Thrombosis may be of more concern when a concomitant reduction in anticoagulant factors is common. In a single study on patients with cirrhosis, the infusion of a four factors complex concentrate allowed safe execution of interventional procedures with no complications [152]. However, the sample size of this uncontrolled study was small.…”

Section: Prothrombin Complex Concentratesmentioning

confidence: 96%

“…This improvement was attained at a mean dosage of 1500 mL, and associated with an increase in thrombin-antithrombin complexes, that are markers of excessive in vivo thrombin generation [149]. Thrombotic events did not occur during infusion, but other complications, including heparininduced thrombocytopenia, were observed [151,152]. Thrombosis may be of more concern when a concomitant reduction in anticoagulant factors is common.…”

Section: Prothrombin Complex Concentratesmentioning

confidence: 99%

Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference

Andriulli

Tripodi

Angeli

et al. 2016

Digestive and Liver Disease

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a b s t r a c tPatients with cirrhosis present with hemostatic alterations secondary to reduced availability of procoagulant and anti-coagulant factors. The net effect of these changes is a rebalanced hemostatic system. The Italian Association of the Study of the Liver (AISF) and the Italian Society of Internal Medicine (SIMI) promoted a consensus conference on the hemostatic balance in patients with cirrhosis. The consensus process started with the review of the literature by a scientific board of experts and ended with a formal consensus meeting in Rome in December 2014. The statements were graded according to quality of evidence and strength of recommendations, and approved by an independent jury. The statements presented here highlight strengths and weaknesses of current laboratory tests to assess bleeding and thrombotic risk in cirrhotic patients, the pathophysiology of hemostatic perturbations in this condition, and outline the optimal management of bleeding and thrombosis in patients with liver cirrhosis.

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Prothrombin complex concentrates in emergency bleeding disorders

Rodgers

2012

American J Hematol

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The use of prothrombin complex concentrates (PCCs), a heterogeneous combination of coagulation factors and counterbalancing inhibitor components, has broadened in recent years beyond single‐factor replacement in conditions such as hemophilia B, to encompass emergency reversal of anticoagulation secondary to oral vitamin K antagonists, ie, warfarin therapy. PCCs also have been studied in other bleeding disorders, such as surgery‐related and trauma‐related bleeding. This review provides an updated examination of the differences among PCC formulations, their potential role in the management of bleeding disorders, and the primary safety issues affecting their use. Am. J. Hematol. 2012. © 2012 Wiley Periodicals, Inc.

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Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage

Abstract: The infusion of pasteurized, nanometre-filtered PCC is an effective, well-tolerated method of correcting prothrombin complex deficiency in patients with severe liver disease with haemorrhage, or before an urgent surgical or invasive diagnostic intervention.

Cited by 83 publications

References 14 publications

Clinical review: Prothrombin complex concentrates - evaluation of safety and thrombogenicity

Clinical review: Prothrombin complex concentrates - evaluation of safety and thrombogenicity

Hemostatic balance in patients with liver cirrhosis: Report of a consensus conference

Prothrombin complex concentrates in emergency bleeding disorders

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