Prothrombin Complex Concentrate in Cardiac Surgery: A Systematic Review and Meta-Analysis

Roman, Marius; Biancari, Fausto; Ahmed, Aamer; Agarwal, Seema; Hadjinikolaou, Leon; Al-Sarraf, Ali; Tsang, Geoff; Oo, Aung; Field, Mark; Santini, Francesco; Mariscalco, Giovanni

doi:10.1016/j.athoracsur.2018.10.013

Cited by 56 publications

(74 citation statements)

References 44 publications

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“…Both plasma and PCCs are effective at restoring thrombin generation in cardiac surgical patients; 129 however, PCCs offer faster, more effective restoration of thrombin generation with reduced volumes and alloantigen exposure 129,130 . A recent systematic review and meta‐analysis of the observational literature comparing 423 patients who received PCCs to 438 who received plasma concluded that PCCs may be associated with a significant reduction in the risk of transfusion and a reduction in the number of units of red cells transfused overall 129 . There was no observed difference between groups in terms of reoperation for bleeding, chest drain output at 24 hours, in‐hospital mortality, stroke, or acute kidney injury.…”

Section: Special Considerations In Refractory Bleedingmentioning

confidence: 99%

Managing the coagulopathy associated with cardiopulmonary bypass

Bartoszko

Karkouti

2021

Journal of Thrombosis and Haemostasis

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Cardiopulmonary bypass (CPB) has allowed for significant surgical advancements, but accompanying risks can be significant and must be expertly managed. One of the foremost risks is coagulopathic bleeding. Increasing levels of bleeding in cardiac surgical patients at the time of separation from CPB are associated with poor outcomes and mortality. CPB‐associated coagulopathy is typically multifactorial and rarely due to inadequate reversal of systemic heparin alone. The components of the bypass circuit induce systemic inflammation and multiple disturbances of the coagulation and fibrinolytic systems. Anticipating coagulopathy is the first step in managing it, and specific patient and procedural risk factors have been identified as predictors of excessive bleeding. Medication management pre‐procedure is critical, as patients undergoing cardiac surgery are commonly on anticoagulants or antiplatelet agents. Important adjuncts to avoid transfusion include antifibrinolytics, and perfusion practices such as red cell salvage, sequestration, and retrograde autologous priming of the bypass circuit have varying degrees of evidence supporting their use. Understanding the patient's coagulation status helps target product replacement and avoid larger volume transfusion. There is increasing recognition of the role of point‐of‐care viscoelastic and functional platelet testing. Common pitfalls in the management of post‐CPB coagulopathy include overdosing protamine for heparin reversal, imperfect laboratory measures of thrombin generation that result in normal or near‐normal laboratory results in the presence of continued bleeding, and delayed recognition of surgical bleeding. While challenging, the effective management of CPB‐associated coagulopathy can significantly improve patient outcomes.

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Section: Special Considerations In Refractory Bleedingmentioning

confidence: 99%

Managing the coagulopathy associated with cardiopulmonary bypass

Bartoszko

Karkouti

2021

Journal of Thrombosis and Haemostasis

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“…55 A more recent meta-analysis, however, did not show any increased risk of stroke with PCC, although the included studies were limited by sample size. 56 Taken together, the hemostatic efficacy of these procoagulants should be weighed against potential thrombotic risks individually.…”

Section: Discussionmentioning

confidence: 99%

Hemostasis Management of Patients Undergoing Emergency Cardiac Surgery After Ticagrelor Loading

Williams

Henderson

Reformato

et al. 2020

Journal of Cardiothoracic and Vascular Anesthesia

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“…In cardiac surgical procedures at high risk for bleeding after separation from CPB such as those involving the aorta with long CPB and aortic cross-clamp times, refractory bleeding diathesis is commonly managed with the initiation of rescue therapy with recombinant activated factor VII. The evidence for prothrombin complex concentrate products, albeit limited, suggests decreased intraoperative transfusion requirements [8,9]. However, there are also substantial risks which include stroke or other thrombotic events which may be life threatening [10].…”

Section: Introductionmentioning

confidence: 99%

Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial

Sera

Stevens

Song

et al. 2020

Preprint

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Background Uncontrolled bleeding after cardiac surgery can be life threatening. Factor eight inhibitor bypassing activity (FEIBA) is a prothrombin complex concentrate empirically used as rescue therapy for correction of refractory bleeding diathesis post cardiopulmonary bypass (CPB). FEIBA use as rescue therapy for bleeding diathesis after CPB has been associated with a low incidence of complications and a reduction in transfusion requirement and re-exploration. The feasibility and efficacy of early administration of FEIBA after termination of CPB have not been studied.Methods We designed a small randomized, double-blinded, placebo-controlled pilot trial to determine the feasibility of a larger trial testing the hypothesis that FEIBA decreases transfusion requirements after CPB. Twelve adult patients undergoing elective major aortic cardiovascular surgery at a tertiary referral hospital were equally randomized to receive a single dose of either FEIBA or matched placebo intraoperatively at the end of CPB. The study was designed to evaluate the feasibility of a larger pivotal trial to determine the effectiveness of FEIBA in reducing the total volume of blood products transfused perioperatively, and its safety profile.Results There were no protocol deviations or events of unblinding, and adverse events were not different between groups. Patients in the FEIBA group were older, more likely to be female, had higher BMI, lower hematocrit, and longer hypothermic circulatory arrest. There were no differences in post randomization blood product transfusions (difference FEIBA vs. placebo: -899 mL; 95%CI: -5,206 to 3,409, p = 0.65).Conclusions This pilot trial confirmed the adequacy of the trial design that involved the early, blinded administration of FEIBA, by demonstrating excellent protocol adherence. We conclude that a larger trial establishing the effectiveness of early prothrombin complex concentrate administration to reduce the use of blood products in the setting of high-risk cardiac surgery is feasible.Trial Registration: ClinicalTrials.gov Identifier: NCT02577614

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Prothrombin Complex Concentrate in Cardiac Surgery: A Systematic Review and Meta-Analysis

Cited by 56 publications

References 44 publications

Managing the coagulopathy associated with cardiopulmonary bypass

Managing the coagulopathy associated with cardiopulmonary bypass

Hemostasis Management of Patients Undergoing Emergency Cardiac Surgery After Ticagrelor Loading

Factor VIII Inhibitor Bypass Activity (FEIBA) for the Reduction of Transfusion in Cardiac Surgery: A Randomized, Double-Blind, Placebo-Controlled, Pilot Trial

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