Fibrinolysis During Liver Transplantation Is Enhanced by Using Solvent/Detergent Virus-Inactivated Plasma (ESDEP®)

Jonge, Jeroen de; Groenland, Theo H. N.; Metselaar, Herold J.; IJzermans, Jan N.M.; Vliet, H. H. D. M. Van; Visser, Loes E.; Tilanus, Hugo W.

doi:10.1097/00000539-200205000-00012

Cited by 62 publications

(44 citation statements)

References 24 publications

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“…Even if aprotinin disguised hyperfibrinolysis in three patients, the incidence would not have been higher than 11%. We cannot acquit SD-plasma as source of the hyperfibrinolysis, but since this rate is similar to those described in reports from centers using standard FFP as their source of plasma, 8,20 other causes emerge as well likely. The four patients with hyperfibrinolysis at baseline had significantly higher MELD-scores than the other patients, and severe liver disease is a known risk factor for developing hyperfibrinolysis.…”

Section: Discussionsupporting

confidence: 59%

“…Patients with intraoperatively detected hyperfibrinolysis received significantly increased numbers of RBC, plasma, and platelet units. This was the case not only in the perioperative period as shown in Figure 2, but also in the period later than 24 hours after start of surgery, when significantly more RBC (median [IQR] 3.5 [2][3][4][5][6][7][8][9] were transfused. No differences were found before the perioperative period (data not shown).…”

Section: Hyperfibrinolysismentioning

confidence: 95%

“…7 Accordingly, SD-plasma has gained increased popularity during the last two decades and has partly replaced FFP in Canada, Mexico, and many European countries. One disadvantage of SD-plasma is that the SD-process inevitably reduces the levels of α2-antiplasmin and protein S, and could increase the risk of hyperfibrinolysis 8 or thromboembolic events such as pulmonary embolism during liver transplantation. 9 In addition to the track record of SD-plasma in Europe during the last two decades, both randomized controlled trials [10][11][12] and critical reviews 4,6 have suggested that these risks are largely theoretical.…”

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confidence: 99%

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Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Haugaa

Taraldsrud

Nyrerød

et al. 2014

Clinical Medicine & Research

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pathogen inactivation, the SD treatment secures pathogen reduction. [2][3][4] Due to dilution and possible neutralization of the responsible antibodies, SD-plasma has a markedly lower rate of allergic/immunologic reactions including no reported cases of transfusion related acute lung injury (TRALI) despite over 10 million units transfused. 5,6 Further, SD-plasma can be regarded as a biopharmaceutical product with Si gnificant perioperative bleeding and transfusions of plasma, red blood cells (RBCs), and platelets are considered part of the normal clinical course of orthotopic liver transplantation (OLT).1 By far the two most common plasma products available today are fresh frozen plasma (FFP) from single blood donors and solvent/detergent (SD)-treated pooled plasma. Whereas FFP does not undergo any kind of Background: Liver transplantation regularly requires transfusion of red blood cells (RBCs), plasma, and platelets. Compared to fresh frozen plasma (FFP) from single blood donors, solvent/detergent-treated plasma (SD-plasma) pooled from several hundred blood donors has advantages with respect to pathogen reduction, standardized content of plasma proteins, and significantly reduced risk of transfusion related lung injury and allergic/ immunologic adverse reactions. However, SD-plasma has been suspected to increase the incidence of hyperfibrinolysis and thromboembolic events. Study Design and Methods:We investigated the transfusion practices, hyperfibrinolysis parameters, and thrombosis outcomes in 195 consecutive adult primary liver transplants in our center using SD-plasma (Octaplas) as the exclusive source of plasma.Results: Perioperatively, median (interquartile range) 4 (1 to 9) RBC-units, 10 (4 to 18) plasma-bags, and 0 (0 to 2) platelet-units were transfused. Hyperfibrinolysis defined as LY30 ≤ 7.5% was detected in 12/138 thrombelastography-monitored patients (9%). These patients received significantly more RBCs, plasma, and platelets than did patients without hyperfibrinolysis. Thrombotic graft complications were observed in three patients (2%). Pulmonary embolism was not observed in any patient. Conclusion:SD-plasma is a safe plasma product for liver transplant recipients, and the incidences of hyperfibrinolysis and thromboembolic events are not significantly different from those seen in centers using FFP.

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Section: Discussionsupporting

confidence: 59%

Section: Hyperfibrinolysismentioning

confidence: 95%

mentioning

confidence: 99%

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Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Haugaa

Taraldsrud

Nyrerød

et al. 2014

Clinical Medicine & Research

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“…In order to decrease the content of protein S there is an increased risk for thrombosis [37] or hyperfibrinolysis may be augmented due to a decreased content of α 2 -AP [38]. Approximately 30% of the fibrinogen is also affected and destroyed [39] during methylene blue pathogen inactivation, which results in reduced fibrin polymerization and again impairs the efficacy of FFP.…”

Section: Management Of Hepatic Coagulopathymentioning

confidence: 99%

Delicate Balance of Bleeding and Thrombosis in End-Stage Liver Disease and Liver Transplantation

Saner

Gieseler²,

Akız³

et al. 2013

Digestion

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Liver transplantation in cirrhotic patients is accompanied by severe bleeding. Indeed, the first 100 recipients of liver allografts transplanted by Thomas E. Starzl died mainly by uncontrolled bleeding. Since then, much progress has been made as to the understanding of the pathophysiology and the treatment of hemostatic disorders in cirrhotic patients. The aim of this review is to provide a state-of-the-art overview on recent developments and treatment options for hemostatic disorder in cirrhotic patients. Patients with end-stage-liver disease (ESLD) do not suffer only from procoagulant deficiency; there is also a lack of natural anticoagulants (i.e. proteins C and S) and profibrinolytics. Conventional laboratory methods such as the determination of the international normalized ratio or the activated partial thromboplastin time cannot predict bleeding complications in these patients. Progressive diagnostic techniques reveal that cirrhotic patients have the same capacity to produce thrombin like healthy volunteers. Moreover, cirrhotic patients - and particularly those with primary biliary cirrhosis or primary sclerosing cholangitis - are at a higher risk for developing thrombosis as compared with healthy controls. Hemostatic alterations are common in cirrhotic patients; they involve both the pro- and the anticoagulant pathways. However, this is a very delicate balance, which may be shifted to either of these pathways by different treatments thereby causing bleeding or thrombosis, respectively.

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“…The levels of coagulation factors, protease inhibitors, and cofactors are tested for each lot before release. Older versions of S/D plasma were associated with hyperfibrinolysis and bleeding; however, changes to the manufacturing process have mitigated the risk of these adverse events . In several studies conducted with the current version of Octaplas, no additional risk of these or other adverse events was identified .…”

Section: Session 2: Implementation Of Prt For Blood Products In the Umentioning

confidence: 99%

Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

et al. 2019

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Fibrinolysis During Liver Transplantation Is Enhanced by Using Solvent/Detergent Virus-Inactivated Plasma (ESDEP®)

Cited by 62 publications

References 24 publications

Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Low Incidence of Hyperfibrinolysis and Thromboembolism in 195 Primary Liver Transplantations Transfused with Solvent/Detergent-Treated Plasma

Delicate Balance of Bleeding and Thrombosis in End-Stage Liver Disease and Liver Transplantation

Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

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